<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/NCT02202980</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-337-1468</org_study_id>
    <nct_id>NCT02202980</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection</brief_title>
  <acronym>LEPTON</acronym>
  <official_title>A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the antiviral efficacy, safety, and tolerability of combination&#xD;
      therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2014</start_date>
  <completion_date type="Actual">May 9, 2016</completion_date>
  <primary_completion_date type="Actual">March 16, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</measure>
    <time_frame>Posttreatment Week 12</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</measure>
    <time_frame>Posttreatment Weeks 4 and 24</time_frame>
    <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Failure</measure>
    <time_frame>Up to Posttreatment Week 24</time_frame>
    <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV RNA &lt; LLOQ While on Treatment by Study Visit</measure>
    <time_frame>Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)</time_frame>
  </secondary_outcome>
  <number_of_arms>15</number_of_arms>
  <enrollment type="Actual">273</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LDV/SOF</intervention_name>
    <description>90/400 mg FDC tablet administered orally once daily</description>
    <arm_group_label>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</arm_group_label>
    <arm_group_label>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</arm_group_label>
    <arm_group_label>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</arm_group_label>
    <other_name>Harvoni®</other_name>
    <other_name>GS-5885/GS-7977</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV</intervention_name>
    <description>Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (&lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)</description>
    <arm_group_label>LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)</arm_group_label>
    <arm_group_label>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOF/VEL</intervention_name>
    <description>400/100 mg FDC tablet administered orally once daily</description>
    <arm_group_label>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</arm_group_label>
    <other_name>Epclusa®</other_name>
    <other_name>GS-7977/GS-5816</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VOX</intervention_name>
    <description>100 mg tablet administered orally once daily with food</description>
    <arm_group_label>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</arm_group_label>
    <arm_group_label>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</arm_group_label>
    <other_name>GS-9857</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Chronic HCV infection&#xD;
&#xD;
          -  Cirrhosis determination (liver biopsy may be required)&#xD;
&#xD;
          -  Screening laboratory values within specified limits&#xD;
&#xD;
          -  Males and females of childbearing potential who engage in heterosexual intercourse&#xD;
             must agree to use protocol specified method(s) of contraception&#xD;
&#xD;
          -  Specific genotype, prior medical history, or concurrent disease as required by the&#xD;
             specific study group&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant illness or any other medical disorder that may&#xD;
             interfere with subject treatment, assessment or compliance with the protocol&#xD;
&#xD;
          -  Pregnant or nursing female, or male with pregnant female partner&#xD;
&#xD;
          -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)&#xD;
&#xD;
          -  Use of any prohibited concomitant medications&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <results_reference>
    <citation>Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A</citation>
  </results_reference>
  <results_reference>
    <citation>Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.</citation>
    <PMID>27240903</PMID>
  </results_reference>
  <results_reference>
    <citation>Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.</citation>
    <PMID>28137593</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>March 15, 2017</results_first_submitted>
  <results_first_submitted_qc>November 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>http://www.gilead.com/research/disclosure-and-transparency</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.</recruitment_details>
      <pre_assignment_details>349 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
          <description>Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)</description>
        </group>
        <group group_id="P2">
          <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="P3">
          <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
          <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="P4">
          <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="P5">
          <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
          <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="P6">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
          <description>Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="P7">
          <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="P8">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="P9">
          <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="P10">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="P11">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="P12">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="P13">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="P14">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or 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="14"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="32"/>
                <participants group_id="P5" count="13"/>
                <participants group_id="P6" count="15"/>
                <participants group_id="P7" count="15"/>
                <participants group_id="P8" count="15"/>
                <participants group_id="P9" count="18"/>
                <participants group_id="P10" count="17"/>
                <participants group_id="P11" count="19"/>
                <participants group_id="P12" count="28"/>
                <participants group_id="P13" count="30"/>
                <participants group_id="P14" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="14"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="12"/>
                <participants group_id="P9" count="14"/>
                <participants group_id="P10" count="17"/>
                <participants group_id="P11" count="19"/>
                <participants group_id="P12" count="25"/>
                <participants group_id="P13" count="19"/>
                <participants group_id="P14" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="3"/>
                <participants group_id="P13" count="11"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="3"/>
                <participants group_id="P13" count="10"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <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_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="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <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="1"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
          <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
        </group>
        <group group_id="B2">
          <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="B3">
          <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
          <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="B4">
          <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="B5">
          <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
          <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="B6">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
          <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="B7">
          <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="B8">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="B9">
          <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="B10">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="B11">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="B12">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="B13">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="B14">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="B15">
          <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="14"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="27"/>
            <count group_id="B4" value="32"/>
            <count group_id="B5" value="13"/>
            <count group_id="B6" value="15"/>
            <count group_id="B7" value="15"/>
            <count group_id="B8" value="15"/>
            <count group_id="B9" value="18"/>
            <count group_id="B10" value="17"/>
            <count group_id="B11" value="19"/>
            <count group_id="B12" value="28"/>
            <count group_id="B13" value="30"/>
            <count group_id="B14" value="4"/>
            <count group_id="B15" value="273"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="18"/>
                    <measurement group_id="B10" value="16"/>
                    <measurement group_id="B11" value="18"/>
                    <measurement group_id="B12" value="26"/>
                    <measurement group_id="B13" value="29"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="257"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="16"/>
                  </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="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="9"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="14"/>
                    <measurement group_id="B11" value="15"/>
                    <measurement group_id="B12" value="19"/>
                    <measurement group_id="B13" value="24"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="191"/>
                  </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="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="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="14"/>
                    <measurement group_id="B8" value="15"/>
                    <measurement group_id="B9" value="18"/>
                    <measurement group_id="B10" value="17"/>
                    <measurement group_id="B11" value="19"/>
                    <measurement group_id="B12" value="28"/>
                    <measurement group_id="B13" value="30"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="272"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="12"/>
                    <measurement group_id="B10" value="16"/>
                    <measurement group_id="B11" value="18"/>
                    <measurement group_id="B12" value="24"/>
                    <measurement group_id="B13" value="27"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <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="2"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="2"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <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="3"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV genotype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Genotype 1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="15"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="24"/>
                    <measurement group_id="B13" value="23"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 1b</title>
              <category_list>
                <category>
                  <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="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="7"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="27"/>
                    <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="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2a or 2c</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <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="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="16"/>
                    <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="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="17"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="19"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 3a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <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="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genotype 4</title>
              <category_list>
                <category>
                  <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="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <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="1"/>
                    <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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="15"/>
                    <measurement group_id="B9" value="18"/>
                    <measurement group_id="B10" value="17"/>
                    <measurement group_id="B11" value="19"/>
                    <measurement group_id="B12" value="11"/>
                    <measurement group_id="B13" value="5"/>
                    <measurement group_id="B14" value="2"/>
                    <measurement group_id="B15" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="15"/>
                    <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="17"/>
                    <measurement group_id="B13" value="25"/>
                    <measurement group_id="B14" value="2"/>
                    <measurement group_id="B15" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL28b Status</title>
          <description>The CC, CT, and TT alleles are different forms of the IL28b gene.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="8"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="21"/>
                    <measurement group_id="B13" value="18"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="3"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="10"/>
                    <measurement group_id="B13" value="5"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 800,000 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="13"/>
                    <measurement group_id="B10" value="14"/>
                    <measurement group_id="B11" value="16"/>
                    <measurement group_id="B12" value="18"/>
                    <measurement group_id="B13" value="25"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HCV Treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Treatment-Naive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="15"/>
                    <measurement group_id="B9" value="18"/>
                    <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="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Experienced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="10"/>
                    <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="17"/>
                    <measurement group_id="B11" value="19"/>
                    <measurement group_id="B12" value="28"/>
                    <measurement group_id="B13" value="30"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="149"/>
                  </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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
        <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
        <time_frame>Posttreatment Week 12</time_frame>
        <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
            <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
            <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O8">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O9">
            <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O11">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O12">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O13">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O14">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)</title>
          <description>SVR12 was defined as HCV RNA &lt; the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.</description>
          <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</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="14"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="15"/>
                <count group_id="O9" value="18"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="28"/>
                <count group_id="O13" value="30"/>
                <count group_id="O14" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="66.1" upper_limit="99.8"/>
                    <measurement group_id="O2" value="96.2" lower_limit="80.4" upper_limit="99.9"/>
                    <measurement group_id="O3" value="74.1" lower_limit="53.7" upper_limit="88.9"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="76.9" lower_limit="46.2" upper_limit="95.0"/>
                    <measurement group_id="O6" value="93.3" lower_limit="68.1" upper_limit="99.8"/>
                    <measurement group_id="O7" value="26.7" lower_limit="7.8" upper_limit="55.1"/>
                    <measurement group_id="O8" value="86.7" lower_limit="59.5" upper_limit="98.3"/>
                    <measurement group_id="O9" value="83.3" lower_limit="58.6" upper_limit="96.4"/>
                    <measurement group_id="O10" value="100.0" lower_limit="80.5" upper_limit="100.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="89.3" lower_limit="71.8" upper_limit="97.7"/>
                    <measurement group_id="O13" value="66.7" lower_limit="47.2" upper_limit="82.7"/>
                    <measurement group_id="O14" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
        <time_frame>Up to 24 weeks</time_frame>
        <population>Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
            <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
            <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O8">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O9">
            <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O11">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O12">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O13">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O14">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event</title>
          <population>Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="15"/>
                <count group_id="O9" value="18"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="28"/>
                <count group_id="O13" value="30"/>
                <count group_id="O14" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
        <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
        <time_frame>Posttreatment Weeks 4 and 24</time_frame>
        <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
            <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
            <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O8">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O9">
            <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O11">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O12">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O13">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O14">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)</title>
          <description>SVR4 and SVR 24 were defined as HCV RNA &lt; LLOQ at 4 and 24 weeks after stopping study treatment, respectively.</description>
          <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</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="14"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="15"/>
                <count group_id="O9" value="18"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="28"/>
                <count group_id="O13" value="30"/>
                <count group_id="O14" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVR4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="66.1" upper_limit="99.8"/>
                    <measurement group_id="O2" value="96.2" lower_limit="80.4" upper_limit="99.9"/>
                    <measurement group_id="O3" value="81.5" lower_limit="61.9" upper_limit="93.7"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="76.9" lower_limit="46.2" upper_limit="95.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O7" value="73.3" lower_limit="44.9" upper_limit="92.2"/>
                    <measurement group_id="O8" value="86.7" lower_limit="59.5" upper_limit="98.3"/>
                    <measurement group_id="O9" value="88.9" lower_limit="65.3" upper_limit="98.6"/>
                    <measurement group_id="O10" value="100.0" lower_limit="80.5" upper_limit="100.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="92.9" lower_limit="76.5" upper_limit="99.1"/>
                    <measurement group_id="O13" value="86.7" lower_limit="69.3" upper_limit="96.2"/>
                    <measurement group_id="O14" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVR24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="66.1" upper_limit="99.8"/>
                    <measurement group_id="O2" value="96.2" lower_limit="80.4" upper_limit="99.9"/>
                    <measurement group_id="O3" value="74.1" lower_limit="53.7" upper_limit="88.9"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="76.9" lower_limit="46.2" upper_limit="95.0"/>
                    <measurement group_id="O6" value="93.3" lower_limit="68.1" upper_limit="99.8"/>
                    <measurement group_id="O7" value="20.0" lower_limit="4.3" upper_limit="48.1"/>
                    <measurement group_id="O8" value="86.7" lower_limit="59.5" upper_limit="98.3"/>
                    <measurement group_id="O9" value="83.3" lower_limit="58.6" upper_limit="96.4"/>
                    <measurement group_id="O10" value="100.0" lower_limit="80.5" upper_limit="100.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="82.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="89.3" lower_limit="71.8" upper_limit="97.7"/>
                    <measurement group_id="O13" value="66.7" lower_limit="47.2" upper_limit="82.7"/>
                    <measurement group_id="O14" value="100.0" lower_limit="39.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Failure</title>
        <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
        <time_frame>Up to Posttreatment Week 24</time_frame>
        <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
            <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
            <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O8">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O9">
            <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O11">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O12">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O13">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O14">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Failure</title>
          <description>Virologic failure was defined as:&#xD;
On-treatment virologic failure:&#xD;
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA &lt; LLOQ while on treatment), or&#xD;
Rebound (confirmed &gt; 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or&#xD;
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)&#xD;
Virologic relapse:&#xD;
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA &lt; LLOQ at last on-treatment visit.</description>
          <population>Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="15"/>
                <count group_id="O9" value="18"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="28"/>
                <count group_id="O13" value="30"/>
                <count group_id="O14" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="22.2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="23.1"/>
                    <measurement group_id="O6" value="6.7"/>
                    <measurement group_id="O7" value="73.3"/>
                    <measurement group_id="O8" value="13.3"/>
                    <measurement group_id="O9" value="11.1"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="10.7"/>
                    <measurement group_id="O13" value="30.0"/>
                    <measurement group_id="O14" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV RNA &lt; LLOQ While on Treatment by Study Visit</title>
        <time_frame>Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
          </group>
          <group group_id="O2">
            <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O3">
            <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
            <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
          </group>
          <group group_id="O4">
            <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
            <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O5">
            <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
            <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
          </group>
          <group group_id="O6">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
            <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
          </group>
          <group group_id="O8">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O9">
            <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O11">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
          </group>
          <group group_id="O12">
            <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O13">
            <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
          </group>
          <group group_id="O14">
            <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
            <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV RNA &lt; LLOQ While on Treatment by Study Visit</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="15"/>
                <count group_id="O9" value="18"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="19"/>
                <count group_id="O12" value="28"/>
                <count group_id="O13" value="30"/>
                <count group_id="O14" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                    <count group_id="O9" value="18"/>
                    <count group_id="O10" value="17"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="28"/>
                    <count group_id="O13" value="30"/>
                    <count group_id="O14" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="28.0"/>
                    <measurement group_id="O3" value="7.4"/>
                    <measurement group_id="O4" value="9.4"/>
                    <measurement group_id="O5" value="7.7"/>
                    <measurement group_id="O6" value="26.7"/>
                    <measurement group_id="O7" value="26.7"/>
                    <measurement group_id="O8" value="26.7"/>
                    <measurement group_id="O9" value="16.7"/>
                    <measurement group_id="O10" value="5.9"/>
                    <measurement group_id="O11" value="5.3"/>
                    <measurement group_id="O12" value="7.1"/>
                    <measurement group_id="O13" value="13.3"/>
                    <measurement group_id="O14" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                    <count group_id="O9" value="18"/>
                    <count group_id="O10" value="17"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="28"/>
                    <count group_id="O13" value="30"/>
                    <count group_id="O14" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3"/>
                    <measurement group_id="O2" value="60.0"/>
                    <measurement group_id="O3" value="40.7"/>
                    <measurement group_id="O4" value="53.1"/>
                    <measurement group_id="O5" value="7.7"/>
                    <measurement group_id="O6" value="66.7"/>
                    <measurement group_id="O7" value="53.3"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="88.9"/>
                    <measurement group_id="O10" value="41.2"/>
                    <measurement group_id="O11" value="42.1"/>
                    <measurement group_id="O12" value="60.7"/>
                    <measurement group_id="O13" value="43.3"/>
                    <measurement group_id="O14" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                    <count group_id="O9" value="18"/>
                    <count group_id="O10" value="17"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="28"/>
                    <count group_id="O13" value="30"/>
                    <count group_id="O14" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="92.0"/>
                    <measurement group_id="O3" value="92.6"/>
                    <measurement group_id="O4" value="87.5"/>
                    <measurement group_id="O5" value="84.6"/>
                    <measurement group_id="O6" value="100.0"/>
                    <measurement group_id="O7" value="100.0"/>
                    <measurement group_id="O8" value="100.0"/>
                    <measurement group_id="O9" value="100.0"/>
                    <measurement group_id="O10" value="76.5"/>
                    <measurement group_id="O11" value="84.2"/>
                    <measurement group_id="O12" value="85.7"/>
                    <measurement group_id="O13" value="93.3"/>
                    <measurement group_id="O14" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="15"/>
                    <count group_id="O9" value="18"/>
                    <count group_id="O10" value="17"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="28"/>
                    <count group_id="O13" value="30"/>
                    <count group_id="O14" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="100.0"/>
                    <measurement group_id="O8" value="100.0"/>
                    <measurement group_id="O9" value="100.0"/>
                    <measurement group_id="O10" value="100.0"/>
                    <measurement group_id="O11" value="94.7"/>
                    <measurement group_id="O12" value="96.4"/>
                    <measurement group_id="O13" value="96.7"/>
                    <measurement group_id="O14" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="17"/>
                    <count group_id="O11" value="19"/>
                    <count group_id="O12" value="28"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="96.3"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="100.0"/>
                    <measurement group_id="O10" value="100.0"/>
                    <measurement group_id="O11" value="100.0"/>
                    <measurement group_id="O12" value="100.0"/>
                    <measurement group_id="O14" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="32"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                    <count group_id="O13" value="0"/>
                    <count group_id="O14" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 weeks plus 30 days</time_frame>
      <desc>Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug</desc>
      <group_list>
        <group group_id="E1">
          <title>LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)</title>
          <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12</description>
        </group>
        <group group_id="E2">
          <title>LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="E3">
          <title>LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)</title>
          <description>LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection</description>
        </group>
        <group group_id="E4">
          <title>LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)</title>
          <description>LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="E5">
          <title>LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)</title>
          <description>LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection</description>
        </group>
        <group group_id="E6">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)</title>
          <description>VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="E7">
          <title>SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis</description>
        </group>
        <group group_id="E8">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="E9">
          <title>SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="E10">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis</description>
        </group>
        <group group_id="E11">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis</description>
        </group>
        <group group_id="E12">
          <title>SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="E13">
          <title>SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis</description>
        </group>
        <group group_id="E14">
          <title>SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)</title>
          <description>SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or 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="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Meniere's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="15" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="14" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="21" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="23" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="4"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Salivary gland enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Catheter site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Chemical burn of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Foreign body in eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Neck injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Skeletal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </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="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Migraine without aura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
              </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="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosures</name_or_title>
      <organization>Gilead Sciences</organization>
      <email>ClinicalTrialDisclosures@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202980
org study id: GS-US-337-1468
nct id: NCT02202980
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will evaluate the antiviral efficacy, safety, and tolerability of combination
      therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
description: SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 24 weeks
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
description: SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
measure: Percentage of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24
description: Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
measure: Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
arm group label: LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
arm group type: Experimental
description: Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.
arm group label: LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
arm group type: Experimental
description: Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.
arm group label: LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
arm group type: Experimental
description: Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.
arm group label: LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
arm group type: Experimental
description: Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.
arm group label: LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
arm group type: Experimental
description: Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.
arm group label: LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
arm group type: Experimental
description: Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
arm group type: Experimental
description: Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.
arm group label: SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
arm group type: Experimental
description: Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
arm group type: Experimental
description: Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
arm group type: Experimental
description: Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
arm group type: Experimental
description: Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
arm group type: Experimental
description: Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
arm group type: Experimental
description: Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
arm group type: Experimental
description: Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
arm group type: Experimental
description: Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.
intervention type: Drug
intervention name: LDV/SOF
description: 90/400 mg FDC tablet administered orally once daily
arm group label: LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
arm group label: LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
arm group label: LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
arm group label: LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
arm group label: LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
arm group label: LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
other name: Harvoni®
other name: GS-5885/GS-7977
intervention type: Drug
intervention name: RBV
description: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
arm group label: LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
arm group label: LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
arm group label: LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
intervention type: Drug
intervention name: SOF/VEL
description: 400/100 mg FDC tablet administered orally once daily
arm group label: SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
arm group label: SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
other name: Epclusa®
other name: GS-7977/GS-5816
intervention type: Drug
intervention name: VOX
description: 100 mg tablet administered orally once daily with food
arm group label: SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
arm group label: SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
arm group label: SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
arm group label: SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
arm group label: SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
other name: GS-9857
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
facility: 
facility: 
country: New Zealand
citation: Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A
citation: Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.
PMID: 27240903
citation: Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.
PMID: 28137593
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Sofosbuvir
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: http://www.gilead.com/research/disclosure-and-transparency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 