<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/NCT03768089</url>
  </required_header>
  <id_info>
    <org_study_id>VX17-121-001</org_study_id>
    <secondary_id>2018-000126-55</secondary_id>
    <nct_id>NCT03768089</nct_id>
  </id_info>
  <brief_title>Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis</brief_title>
  <official_title>A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vertex Pharmaceuticals Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vertex Pharmaceuticals Incorporated</source>
  <oversight_info>
    <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>
      The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy&#xD;
      subjects and in subjects with cystic fibrosis (CF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From Day 1 Through Safety Follow-up (up to Day 15 for Part A [except Cohorts A3 and A9], up to Day 26 for Cohort A3, up to Day 34 for Cohort A9, up to Day 20 for Part B, up to Day 24 for Part C and up to Week 9 for Part D)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A: Maximum Observed Concentration (Cmax) of VX-121</measure>
    <time_frame>Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121</measure>
    <time_frame>Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Maximum Observed Concentration (Cmax) of VX-121</measure>
    <time_frame>Day 1, Day 5, and Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Area Under the Concentration Versus Time Curve During the Dosing Interval (AUCtau) of VX-121</measure>
    <time_frame>Day 1, Day 5, and Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121</measure>
    <time_frame>Pre-dose at Day 5 and Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and, IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Day 1, Day 7, and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Day 1, Day 7, and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Pre-dose at Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Day 1 and Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Day 1 and Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Pre-dose at Day 8, Day 15, and Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Absolute Change in Sweat Chloride (SwCl) Concentrations</measure>
    <time_frame>From Baseline Through Day 29</time_frame>
    <description>Sweat samples were collected using an approved collection device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)</measure>
    <time_frame>From Baseline Through Day 29</time_frame>
    <description>FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.</description>
  </secondary_outcome>
  <number_of_arms>18</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received single dose of placebo matched to VX-121.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 10 milligrams (mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 40 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A5)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 60 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-121 (Cohort A9)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Pooled Placebo (Cohorts B1-4)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo matched to VX-121 for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: VX-121 (Cohort B1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 10 mg once daily (qd) for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: VX-121 (Cohort B2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 20 mg qd for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: VX-121 (Cohort B3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 40 mg qd for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: VX-121 (Cohort B4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 60 mg qd for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: Pooled Placebo (Cohorts C1-3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo matched to VX-121/TEZ/IVA for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: VX-121 (Cohort C1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: VX-121 (Cohort C2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: VX-121 (Cohort C3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: VX-121/TEZ/IVA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (matched to VX-121 suspension)</intervention_name>
    <description>Placebo matched to VX-121 suspension for oral administration.</description>
    <arm_group_label>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A3)</arm_group_label>
    <arm_group_label>Part B: Pooled Placebo (Cohorts B1-4)</arm_group_label>
    <arm_group_label>Part C: Pooled Placebo (Cohorts C1-3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-121 (Suspension)</intervention_name>
    <description>Suspension for oral administration.</description>
    <arm_group_label>Part A: VX-121 (Cohort A1)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A2)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A3)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A4)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A5)</arm_group_label>
    <arm_group_label>Part A: VX-121 (Cohort A9)</arm_group_label>
    <arm_group_label>Part B: VX-121 (Cohort B1)</arm_group_label>
    <arm_group_label>Part B: VX-121 (Cohort B2)</arm_group_label>
    <arm_group_label>Part B: VX-121 (Cohort B3)</arm_group_label>
    <arm_group_label>Part B: VX-121 (Cohort B4)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C1)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C2)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TEZ/IVA</intervention_name>
    <description>Fixed-dose combination tablet for oral administration.</description>
    <arm_group_label>Part C: VX-121 (Cohort C1)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C2)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C3)</arm_group_label>
    <arm_group_label>Part D: VX-121/TEZ/IVA</arm_group_label>
    <other_name>VX-661/VX-770</other_name>
    <other_name>tezacaftor/ivacaftor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVA</intervention_name>
    <description>Tablet for oral administration.</description>
    <arm_group_label>Part C: VX-121 (Cohort C1)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C2)</arm_group_label>
    <arm_group_label>Part C: VX-121 (Cohort C3)</arm_group_label>
    <arm_group_label>Part D: VX-121/TEZ/IVA</arm_group_label>
    <other_name>VX-770</other_name>
    <other_name>ivacaftor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (matched to TEZ/IVA)</intervention_name>
    <description>Placebo matched to TEZ/IVA for oral administration.</description>
    <arm_group_label>Part C: Pooled Placebo (Cohorts C1-3)</arm_group_label>
    <arm_group_label>Part D: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (matched to IVA)</intervention_name>
    <description>Placebo matched to IVA for oral administration.</description>
    <arm_group_label>Part C: Pooled Placebo (Cohorts C1-3)</arm_group_label>
    <arm_group_label>Part D: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-121 (Tablet)</intervention_name>
    <description>Tablet for oral administration.</description>
    <arm_group_label>Part A: VX-121 (Cohort A9)</arm_group_label>
    <arm_group_label>Part D: VX-121/TEZ/IVA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (matched to VX-121 tablet)</intervention_name>
    <description>Placebo matched to VX-121 tablet for oral administration.</description>
    <arm_group_label>Part D: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Part A, B, and C: Healthy Volunteers&#xD;
&#xD;
               -  Female subjects must be of non-childbearing potential&#xD;
&#xD;
               -  Between the ages of 18 and 55 years, inclusive&#xD;
&#xD;
               -  Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight&#xD;
                  &gt;50 kg&#xD;
&#xD;
          -  Part D: Subjects with CF&#xD;
&#xD;
               -  Heterozygous for F508del and an MF mutation (F/MF)&#xD;
&#xD;
               -  FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height&#xD;
&#xD;
               -  Body weight ≥35 kg&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Part A, B and C: Healthy Volunteers&#xD;
&#xD;
               -  Any condition possibly affecting drug absorption&#xD;
&#xD;
               -  History of febrile illness or other acute illness within 5 days before the first&#xD;
                  study drug dose&#xD;
&#xD;
          -  Part D: Subjects with CF&#xD;
&#xD;
               -  History of clinically significant cirrhosis with or without portal hypertension&#xD;
&#xD;
               -  History of solid organ or hematological transplantation&#xD;
&#xD;
               -  Lung infection with organisms associated with a more rapid decline in pulmonary&#xD;
                  status&#xD;
&#xD;
        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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HagaZiekenhuis van den Haag</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences Onderzoekscentrum UMCG</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC St. Radboud</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medicines Evaluation Unit</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>April 29, 2022</results_first_submitted>
  <results_first_submitted_qc>June 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 14, 2022</results_first_posted>
  <disposition_first_submitted>May 1, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 17, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 14, 2022</disposition_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivacaftor</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03768089/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03768089/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 115 unique participants enrolled in this study.</recruitment_details>
      <pre_assignment_details>This study included 4 parts: Parts A, B, and C were conducted in healthy adult participants; Part D was conducted in adult cystic fibrosis (CF) participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</title>
          <description>Participants received single dose of placebo matched to VX-121.</description>
        </group>
        <group group_id="P2">
          <title>Part A: VX-121 (Cohort A1)</title>
          <description>Participants received single dose of VX-121 10 milligrams (mg).</description>
        </group>
        <group group_id="P3">
          <title>Part A: VX-121 (Cohort A2)</title>
          <description>Participants received single dose of VX-121 20 mg.</description>
        </group>
        <group group_id="P4">
          <title>Part A: VX-121 (Cohort A3)</title>
          <description>Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.</description>
        </group>
        <group group_id="P5">
          <title>Part A: VX-121 (Cohort A4)</title>
          <description>Participants received single dose of VX-121 40 mg.</description>
        </group>
        <group group_id="P6">
          <title>Part A: VX-121 (Cohort A5)</title>
          <description>Participants received single dose of VX-121 60 mg.</description>
        </group>
        <group group_id="P7">
          <title>Part A: VX-121 (Cohort A9)</title>
          <description>Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.</description>
        </group>
        <group group_id="P8">
          <title>Part B: Pooled Placebo (Cohorts B1-4)</title>
          <description>Participants received placebo matched to VX-121 for 10 days.</description>
        </group>
        <group group_id="P9">
          <title>Part B: VX-121 (Cohort B1)</title>
          <description>Participants received VX-121 10 mg once daily (qd) for 10 days.</description>
        </group>
        <group group_id="P10">
          <title>Part B: VX-121 (Cohort B2)</title>
          <description>Participants received VX-121 20 mg qd for 10 days.</description>
        </group>
        <group group_id="P11">
          <title>Part B: VX-121 (Cohort B3)</title>
          <description>Participants received VX-121 40 mg qd for 10 days.</description>
        </group>
        <group group_id="P12">
          <title>Part B: VX-121 (Cohort B4)</title>
          <description>Participants received VX-121 60 mg qd for 10 days.</description>
        </group>
        <group group_id="P13">
          <title>Part C: Pooled Placebo (Cohorts C1-3)</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA for 14 days.</description>
        </group>
        <group group_id="P14">
          <title>Part C: VX-121 (Cohort C1)</title>
          <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) for 14 days.</description>
        </group>
        <group group_id="P15">
          <title>Part C: VX-121 (Cohort C2)</title>
          <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="P16">
          <title>Part C: VX-121 (Cohort C3)</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="P17">
          <title>Part D: Placebo</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
        </group>
        <group group_id="P18">
          <title>Part D: VX-121/TEZ/IVA</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6">One participant who participated in A2 also participated in B3.</participants>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants 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="9"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part C</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="8"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="7"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="7"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized, Never Dosed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part D</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis population included all participants who received at least 1 dose of study drug. The participant who participated in Parts A2 and B3 counted only once in Part A: VX-121 (Cohort A2) reporting arm.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</title>
          <description>Participants received single dose of placebo matched to VX-121.</description>
        </group>
        <group group_id="B2">
          <title>Part A: VX-121 (Cohort A1)</title>
          <description>Participants received single dose of VX-121 10 mg.</description>
        </group>
        <group group_id="B3">
          <title>Part A: VX-121 (Cohort A2)</title>
          <description>Participants received single dose of VX-121 20 mg.</description>
        </group>
        <group group_id="B4">
          <title>Part A: VX-121 (Cohort A3)</title>
          <description>Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.</description>
        </group>
        <group group_id="B5">
          <title>Part A: VX-121 (Cohort A4)</title>
          <description>Participants received single dose of VX-121 40 mg.</description>
        </group>
        <group group_id="B6">
          <title>Part A: VX-121 (Cohort A5)</title>
          <description>Participants received single dose of VX-121 60 mg.</description>
        </group>
        <group group_id="B7">
          <title>Part A: Cohort A9</title>
          <description>Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.</description>
        </group>
        <group group_id="B8">
          <title>Part B: Pooled Placebo (Cohorts B1-4)</title>
          <description>Participants received placebo matched to VX-121 for 10 days.</description>
        </group>
        <group group_id="B9">
          <title>Part B: VX-121 (Cohort B1)</title>
          <description>Participants received VX-121 10 mg qd for 10 days.</description>
        </group>
        <group group_id="B10">
          <title>Part B: VX-121 (Cohort B2)</title>
          <description>Participants received VX-121 20 mg qd for 10 days.</description>
        </group>
        <group group_id="B11">
          <title>Part B: VX-121 (Cohort B3)</title>
          <description>Participants received VX-121 40 mg qd for 10 days.</description>
        </group>
        <group group_id="B12">
          <title>Part B: VX-121 (Cohort B4)</title>
          <description>Participants received VX-121 60 mg qd for 10 days.</description>
        </group>
        <group group_id="B13">
          <title>Part C: Pooled Placebo (Cohorts C1-3)</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA in for 14 days.</description>
        </group>
        <group group_id="B14">
          <title>Part C: VX-121 (Cohort C1)</title>
          <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="B15">
          <title>Part C: VX-121 (Cohort C2)</title>
          <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="B16">
          <title>Part C: VX-121 (Cohort C3)</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="B17">
          <title>Part D: Placebo</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
        </group>
        <group group_id="B18">
          <title>Part D: VX-121/TEZ/IVA</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
        </group>
        <group group_id="B19">
          <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="8"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="8"/>
            <count group_id="B8" value="9"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="5"/>
            <count group_id="B12" value="6"/>
            <count group_id="B13" value="6"/>
            <count group_id="B14" value="6"/>
            <count group_id="B15" value="7"/>
            <count group_id="B16" value="6"/>
            <count group_id="B17" value="3"/>
            <count group_id="B18" value="9"/>
            <count group_id="B19" value="114"/>
          </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 group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="7"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="3"/>
                    <measurement group_id="B18" value="9"/>
                    <measurement group_id="B19" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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 group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                  </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="0"/>
                    <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="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <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 group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="3"/>
                    <measurement group_id="B18" value="8"/>
                    <measurement group_id="B19" value="109"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <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="1"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="5"/>
                    <measurement group_id="B15" value="7"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="3"/>
                    <measurement group_id="B18" value="9"/>
                    <measurement group_id="B19" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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="1"/>
                    <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="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <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="2"/>
                    <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="1"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <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="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <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="1"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="5"/>
                    <measurement group_id="B13" value="4"/>
                    <measurement group_id="B14" value="5"/>
                    <measurement group_id="B15" value="5"/>
                    <measurement group_id="B16" value="5"/>
                    <measurement group_id="B17" value="3"/>
                    <measurement group_id="B18" value="8"/>
                    <measurement group_id="B19" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <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="1"/>
                    <measurement group_id="B8" value="1"/>
                    <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="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <time_frame>From Day 1 Through Safety Follow-up (up to Day 15 for Part A [except Cohorts A3 and A9], up to Day 26 for Cohort A3, up to Day 34 for Cohort A9, up to Day 20 for Part B, up to Day 24 for Part C and up to Week 9 for Part D)</time_frame>
        <population>Safety Set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</title>
            <description>Participants received single dose of placebo matched to VX-121.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-121 (Cohort A1)</title>
            <description>Participants received single dose of VX-121 10 mg.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-121 (Cohort A2)</title>
            <description>Participants received single dose of VX-121 20 mg.</description>
          </group>
          <group group_id="O4">
            <title>Part A: VX-121 (Cohort A3)</title>
            <description>Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.</description>
          </group>
          <group group_id="O5">
            <title>Part A: VX-121 (Cohort A4)</title>
            <description>Participants received single dose of VX-121 40 mg.</description>
          </group>
          <group group_id="O6">
            <title>Part A: VX-121 (Cohort A5)</title>
            <description>Participants received single dose of VX-121 60 mg.</description>
          </group>
          <group group_id="O7">
            <title>Part A: VX-121 (Cohort A9)</title>
            <description>Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.</description>
          </group>
          <group group_id="O8">
            <title>Part B: Pooled Placebo (Cohorts B1-4)</title>
            <description>Participants received placebo matched to VX-121 for 10 days.</description>
          </group>
          <group group_id="O9">
            <title>Part B: VX-121 (Cohort B1)</title>
            <description>Participants received VX-121 10 mg qd for 10 days.</description>
          </group>
          <group group_id="O10">
            <title>Part B: VX-121 (Cohort B2)</title>
            <description>Participants received VX-121 20 mg qd for 10 days.</description>
          </group>
          <group group_id="O11">
            <title>Part B: VX-121 (Cohort B3)</title>
            <description>Participants received VX-121 40 mg qd for 10 days.</description>
          </group>
          <group group_id="O12">
            <title>Part B: VX-121 (Cohort B4)</title>
            <description>Participants received VX-121 60 mg qd for 10 days.</description>
          </group>
          <group group_id="O13">
            <title>Part C: Pooled Placebo (Cohorts C1-3)</title>
            <description>Participants received placebo matched to VX-121/TEZ/IVA for 14 days.</description>
          </group>
          <group group_id="O14">
            <title>Part C: VX-121 (Cohort C1)</title>
            <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O15">
            <title>Part C: VX-121 (Cohort C2)</title>
            <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O16">
            <title>Part C: VX-121 (Cohort C3)</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O17">
            <title>Part D: Placebo</title>
            <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
          </group>
          <group group_id="O18">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <population>Safety Set included all participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="7"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="3"/>
                <count group_id="O18" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants With TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="7"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="5"/>
                    <measurement group_id="O13" value="4"/>
                    <measurement group_id="O14" value="3"/>
                    <measurement group_id="O15" value="6"/>
                    <measurement group_id="O16" value="3"/>
                    <measurement group_id="O17" value="2"/>
                    <measurement group_id="O18" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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 group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="1"/>
                    <measurement group_id="O18" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Maximum Observed Concentration (Cmax) of VX-121</title>
        <time_frame>Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose</time_frame>
        <population>The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and for whom the primary PK data are considered sufficient and interpretable.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: VX-121 (Cohort A1)</title>
            <description>Participants received single dose of VX-121 10 mg.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-121 (Cohort A2)</title>
            <description>Participants received single dose of VX-121 20 mg.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-121 (Cohort A3: Without Milk)</title>
            <description>Participants received single dose of VX-121 5 mg without milk.</description>
          </group>
          <group group_id="O4">
            <title>Part A: VX-121 (Cohort A3: With Milk)</title>
            <description>Participants received single dose of VX-121 5 mg with milk.</description>
          </group>
          <group group_id="O5">
            <title>Part A: VX-121 (Cohort A4)</title>
            <description>Participants received single dose of VX-121 40 mg.</description>
          </group>
          <group group_id="O6">
            <title>Part A: VX-121 (Cohort A5)</title>
            <description>Participants received single dose of VX-121 60 mg.</description>
          </group>
          <group group_id="O7">
            <title>Part A: VX-121 (Cohort A9: Suspension)</title>
            <description>Participants received single dose of VX-121 10 mg suspension on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part A: VX-121 (Cohort A9: Tablet Without Milk)</title>
            <description>Participants received single dose of VX-121 10 mg tablet without milk on Day 9.</description>
          </group>
          <group group_id="O9">
            <title>Part A: VX-121 (Cohort A9: Tablet With Milk)</title>
            <description>Participants received single dose of VX-121 10 mg tablet with milk on Day 17.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Maximum Observed Concentration (Cmax) of VX-121</title>
          <population>The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and for whom the primary PK data are considered sufficient and interpretable.</population>
          <units>microgram per milliliter (mcg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="8"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.134" spread="0.0295"/>
                    <measurement group_id="O2" value="0.247" spread="0.0515"/>
                    <measurement group_id="O3" value="0.0705" spread="0.0152"/>
                    <measurement group_id="O4" value="0.061" spread="0.0143"/>
                    <measurement group_id="O5" value="0.893" spread="0.216"/>
                    <measurement group_id="O6" value="1.04" spread="0.263"/>
                    <measurement group_id="O7" value="0.181" spread="0.0458"/>
                    <measurement group_id="O8" value="0.178" spread="0.0447"/>
                    <measurement group_id="O9" value="0.156" spread="0.0352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121</title>
        <time_frame>Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose</time_frame>
        <population>PK set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: VX-121 (Cohort A1)</title>
            <description>Participants received single dose of VX-121 10 mg.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-121 (Cohort A2)</title>
            <description>Participants received single dose of VX-121 20 mg.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-121 (Cohort A3: Without Milk)</title>
            <description>Participants received single dose of VX-121 5 mg without milk.</description>
          </group>
          <group group_id="O4">
            <title>Part A: VX-121 (Cohort A3: With Milk)</title>
            <description>Participants received single dose of VX-121 5 mg with milk.</description>
          </group>
          <group group_id="O5">
            <title>Part A: VX-121 (Cohort A4)</title>
            <description>Participants received single dose of VX-121 40 mg.</description>
          </group>
          <group group_id="O6">
            <title>Part A: VX-121 (Cohort A5)</title>
            <description>Participants received single dose of VX-121 60 mg.</description>
          </group>
          <group group_id="O7">
            <title>Part A: VX-121 (Cohort A9: Suspension)</title>
            <description>Participants received single dose of VX-121 10 mg suspension on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part A: VX-121 (Cohort A9: Tablet Without Milk)</title>
            <description>Participants received single dose of VX-121 10 mg tablet without milk on Day 9.</description>
          </group>
          <group group_id="O9">
            <title>Part A: VX-121 (Cohort A9: Tablet With Milk)</title>
            <description>Participants received single dose of VX-121 10 mg tablet with milk on Day 17.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121</title>
          <population>PK set.</population>
          <units>microgram*hour per milliliter (mcg*h/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="8"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.72" spread="1.93"/>
                    <measurement group_id="O2" value="20.7" spread="7.03"/>
                    <measurement group_id="O3" value="6.32" spread="2.54"/>
                    <measurement group_id="O4" value="5.36" spread="2.09"/>
                    <measurement group_id="O5" value="72.2" spread="28.9"/>
                    <measurement group_id="O6" value="66.6" spread="9.18"/>
                    <measurement group_id="O7" value="15.7" spread="3.88"/>
                    <measurement group_id="O8" value="14.6" spread="3.85"/>
                    <measurement group_id="O9" value="13.1" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Maximum Observed Concentration (Cmax) of VX-121</title>
        <time_frame>Day 1, Day 5, and Day 10</time_frame>
        <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-121 (Cohort B1)</title>
            <description>Participants received VX-121 10 mg qd for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-121 (Cohort B2)</title>
            <description>Participants received VX-121 20 mg qd for 10 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-121 (Cohort B3)</title>
            <description>Participants received VX-121 40 mg qd for 10 days.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-121 (Cohort B4)</title>
            <description>Participants received VX-121 60 mg qd for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Maximum Observed Concentration (Cmax) of VX-121</title>
          <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.153" spread="0.0260"/>
                    <measurement group_id="O2" value="0.418" spread="0.0667"/>
                    <measurement group_id="O3" value="0.803" spread="0.0529"/>
                    <measurement group_id="O4" value="1.43" spread="0.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.497" spread="0.0889"/>
                    <measurement group_id="O2" value="1.41" spread="0.316"/>
                    <measurement group_id="O3" value="2.67" spread="0.564"/>
                    <measurement group_id="O4" value="4.36" spread="0.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.574" spread="0.122"/>
                    <measurement group_id="O2" value="1.94" spread="0.410"/>
                    <measurement group_id="O3" value="3.07" spread="0.667"/>
                    <measurement group_id="O4" value="5.07" spread="0.803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Area Under the Concentration Versus Time Curve During the Dosing Interval (AUCtau) of VX-121</title>
        <time_frame>Day 1, Day 5, and Day 10</time_frame>
        <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-121 (Cohort B1)</title>
            <description>Participants received VX-121 10 mg qd for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-121 (Cohort B2)</title>
            <description>Participants received VX-121 20 mg qd for 10 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-121 (Cohort B3)</title>
            <description>Participants received VX-121 40 mg qd for 10 days.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-121 (Cohort B4)</title>
            <description>Participants received VX-121 60 mg qd for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Area Under the Concentration Versus Time Curve During the Dosing Interval (AUCtau) of VX-121</title>
          <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="0.435"/>
                    <measurement group_id="O2" value="7.11" spread="1.27"/>
                    <measurement group_id="O3" value="14.4" spread="1.08"/>
                    <measurement group_id="O4" value="27.5" spread="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="1.84"/>
                    <measurement group_id="O2" value="30.1" spread="6.76"/>
                    <measurement group_id="O3" value="53.8" spread="10.7"/>
                    <measurement group_id="O4" value="86.6" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="2.52"/>
                    <measurement group_id="O2" value="38.2" spread="9.26"/>
                    <measurement group_id="O3" value="58.7" spread="12.6"/>
                    <measurement group_id="O4" value="97.5" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121</title>
        <time_frame>Pre-dose at Day 5 and Day 10</time_frame>
        <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-121 (Cohort B1)</title>
            <description>Participants received VX-121 10 mg qd for 10 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-121 (Cohort B2)</title>
            <description>Participants received VX-121 20 mg qd for 10 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-121 (Cohort B3)</title>
            <description>Participants received VX-121 40 mg qd for 10 days.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-121 (Cohort B4)</title>
            <description>Participants received VX-121 60 mg qd for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121</title>
          <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.391" spread="0.0694"/>
                    <measurement group_id="O2" value="1.16" spread="0.266"/>
                    <measurement group_id="O3" value="2.07" spread="0.537"/>
                    <measurement group_id="O4" value="2.94" spread="0.759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.484" spread="0.109"/>
                    <measurement group_id="O2" value="1.64" spread="0.414"/>
                    <measurement group_id="O3" value="2.40" spread="0.637"/>
                    <measurement group_id="O4" value="3.81" spread="0.792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and, IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Day 1, Day 7, and Day 14</time_frame>
        <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-121 (Cohort C1)</title>
            <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-121 (Cohort C2)</title>
            <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-121 (Cohort C3)</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and, IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.212" spread="0.0501"/>
                    <measurement group_id="O2" value="0.408" spread="0.122"/>
                    <measurement group_id="O3" value="0.0728" spread="0.0102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.735"/>
                    <measurement group_id="O2" value="1.77" spread="0.416"/>
                    <measurement group_id="O3" value="0.364" spread="0.122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.39" spread="0.651"/>
                    <measurement group_id="O2" value="2.14" spread="0.476"/>
                    <measurement group_id="O3" value="0.385" spread="0.108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.97" spread="1.33"/>
                    <measurement group_id="O2" value="6.75" spread="0.936"/>
                    <measurement group_id="O3" value="5.11" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.48" spread="3.09"/>
                    <measurement group_id="O2" value="8.72" spread="0.561"/>
                    <measurement group_id="O3" value="7.50" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.49" spread="3.76"/>
                    <measurement group_id="O2" value="9.08" spread="0.547"/>
                    <measurement group_id="O3" value="7.27" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="0.327"/>
                    <measurement group_id="O2" value="1.24" spread="0.399"/>
                    <measurement group_id="O3" value="1.12" spread="0.259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.07" spread="1.10"/>
                    <measurement group_id="O2" value="6.48" spread="1.48"/>
                    <measurement group_id="O3" value="5.20" spread="0.606"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.44" spread="1.36"/>
                    <measurement group_id="O2" value="8.12" spread="1.41"/>
                    <measurement group_id="O3" value="6.70" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.521" spread="0.191"/>
                    <measurement group_id="O2" value="0.622" spread="0.390"/>
                    <measurement group_id="O3" value="0.662" spread="0.320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.79" spread="2.03"/>
                    <measurement group_id="O2" value="6.16" spread="2.17"/>
                    <measurement group_id="O3" value="5.56" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="2.88"/>
                    <measurement group_id="O2" value="8.78" spread="3.54"/>
                    <measurement group_id="O3" value="9.07" spread="6.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="0.158"/>
                    <measurement group_id="O2" value="1.00" spread="0.235"/>
                    <measurement group_id="O3" value="0.770" spread="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="1.27"/>
                    <measurement group_id="O2" value="1.40" spread="0.288"/>
                    <measurement group_id="O3" value="1.37" spread="0.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="1.20"/>
                    <measurement group_id="O2" value="1.35" spread="0.231"/>
                    <measurement group_id="O3" value="1.20" spread="0.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" spread="0.573"/>
                    <measurement group_id="O2" value="2.34" spread="0.602"/>
                    <measurement group_id="O3" value="1.51" spread="0.349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="1.80"/>
                    <measurement group_id="O2" value="3.42" spread="0.534"/>
                    <measurement group_id="O3" value="2.65" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="1.86"/>
                    <measurement group_id="O2" value="2.97" spread="0.640"/>
                    <measurement group_id="O3" value="3.14" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.779" spread="0.343"/>
                    <measurement group_id="O2" value="1.29" spread="0.796"/>
                    <measurement group_id="O3" value="1.24" spread="0.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="0.889"/>
                    <measurement group_id="O2" value="2.62" spread="1.20"/>
                    <measurement group_id="O3" value="1.88" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" spread="0.941"/>
                    <measurement group_id="O2" value="2.26" spread="0.744"/>
                    <measurement group_id="O3" value="2.55" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Day 1, Day 7, and Day 14</time_frame>
        <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-121 (Cohort C1)</title>
            <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-121 (Cohort C2)</title>
            <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-121 (Cohort C3)</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set. Here, the &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified time points.</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" spread="0.813"/>
                    <measurement group_id="O2" value="7.96" spread="0.789"/>
                    <measurement group_id="O3" value="1.18" spread="0.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" spread="10.6"/>
                    <measurement group_id="O2" value="35.4" spread="8.27"/>
                    <measurement group_id="O3" value="6.52" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="14.5"/>
                    <measurement group_id="O2" value="41.1" spread="8.29"/>
                    <measurement group_id="O3" value="7.34" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.1" spread="16.6"/>
                    <measurement group_id="O2" value="50.9" spread="7.11"/>
                    <measurement group_id="O3" value="44.6" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" spread="51.6"/>
                    <measurement group_id="O2" value="103" spread="13.9"/>
                    <measurement group_id="O3" value="88.8" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138" spread="60.8"/>
                    <measurement group_id="O2" value="112" spread="10.4"/>
                    <measurement group_id="O3" value="87.6" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="7.03"/>
                    <measurement group_id="O2" value="24.9" spread="6.61"/>
                    <measurement group_id="O3" value="20.7" spread="4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107" spread="24.8"/>
                    <measurement group_id="O2" value="130" spread="22.3"/>
                    <measurement group_id="O3" value="109" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139" spread="29.7"/>
                    <measurement group_id="O2" value="167" spread="24.7"/>
                    <measurement group_id="O3" value="142" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.68" spread="2.49"/>
                    <measurement group_id="O2" value="9.61" spread="5.51"/>
                    <measurement group_id="O3" value="7.57" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103" spread="41.1"/>
                    <measurement group_id="O2" value="130" spread="46.7"/>
                    <measurement group_id="O3" value="117" spread="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143" spread="64.1"/>
                    <measurement group_id="O2" value="194" spread="82.7"/>
                    <measurement group_id="O3" value="200" spread="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.16" spread="1.36"/>
                    <measurement group_id="O2" value="5.85" spread="1.64"/>
                    <measurement group_id="O3" value="4.30" spread="0.504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" spread="12.3"/>
                    <measurement group_id="O2" value="11.6" spread="3.26"/>
                    <measurement group_id="O3" value="11.0" spread="3.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="10.7"/>
                    <measurement group_id="O2" value="11.2" spread="2.75"/>
                    <measurement group_id="O3" value="9.02" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="3.01"/>
                    <measurement group_id="O2" value="14.1" spread="1.68"/>
                    <measurement group_id="O3" value="9.37" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" spread="17.3"/>
                    <measurement group_id="O2" value="27.3" spread="4.79"/>
                    <measurement group_id="O3" value="22.3" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" spread="17.3"/>
                    <measurement group_id="O2" value="25.3" spread="4.35"/>
                    <measurement group_id="O3" value="24.2" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" spread="1.63"/>
                    <measurement group_id="O2" value="9.42" spread="4.83"/>
                    <measurement group_id="O3" value="4.99" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" spread="9.34"/>
                    <measurement group_id="O2" value="26.5" spread="12.7"/>
                    <measurement group_id="O3" value="19.2" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" spread="10.2"/>
                    <measurement group_id="O2" value="22.6" spread="8.19"/>
                    <measurement group_id="O3" value="26.4" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Pre-dose at Day 7 and Day 14</time_frame>
        <population>PK set. Here, the &quot;overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-121 (Cohort C1)</title>
            <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-121 (Cohort C2)</title>
            <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-121 (Cohort C3)</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set. Here, the &quot;overall number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;number analyzed&quot; signifies those participants who were evaluable for this outcome measure at specified timepoints.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.916" spread="0.369"/>
                    <measurement group_id="O2" value="1.37" spread="0.321"/>
                    <measurement group_id="O3" value="0.258" spread="0.0426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="0.665"/>
                    <measurement group_id="O2" value="1.72" spread="0.452"/>
                    <measurement group_id="O3" value="0.357" spread="0.0966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="1.84"/>
                    <measurement group_id="O2" value="2.57" spread="0.776"/>
                    <measurement group_id="O3" value="2.31" spread="0.735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="2.50"/>
                    <measurement group_id="O2" value="3.27" spread="0.646"/>
                    <measurement group_id="O3" value="2.27" spread="0.851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.09" spread="1.22"/>
                    <measurement group_id="O2" value="4.53" spread="0.512"/>
                    <measurement group_id="O3" value="3.96" spread="0.685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.45" spread="1.46"/>
                    <measurement group_id="O2" value="6.40" spread="1.17"/>
                    <measurement group_id="O3" value="5.03" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.30" spread="1.66"/>
                    <measurement group_id="O2" value="5.08" spread="2.06"/>
                    <measurement group_id="O3" value="4.75" spread="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.20" spread="2.60"/>
                    <measurement group_id="O2" value="5.51" spread="1.72"/>
                    <measurement group_id="O3" value="8.63" spread="6.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.834"/>
                    <measurement group_id="O2" value="0.768" spread="0.230"/>
                    <measurement group_id="O3" value="0.780" spread="0.317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="0.889"/>
                    <measurement group_id="O2" value="0.750" spread="0.252"/>
                    <measurement group_id="O3" value="0.601" spread="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="1.53"/>
                    <measurement group_id="O2" value="2.00" spread="0.589"/>
                    <measurement group_id="O3" value="1.67" spread="0.334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="1.37"/>
                    <measurement group_id="O2" value="1.87" spread="0.509"/>
                    <measurement group_id="O3" value="1.73" spread="0.977"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="0.763"/>
                    <measurement group_id="O2" value="2.09" spread="1.11"/>
                    <measurement group_id="O3" value="1.67" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.60" spread="0.926"/>
                    <measurement group_id="O2" value="1.85" spread="0.738"/>
                    <measurement group_id="O3" value="2.27" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Day 1 and Day 15</time_frame>
        <population>PK set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0553" spread="0.0207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.389" spread="0.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.80" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.26" spread="0.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.243" spread="0.0629"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.99" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.745" spread="0.279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" spread="0.472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="0.478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread="0.829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.531" spread="0.229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Day 1 and Day 15</time_frame>
        <population>PK set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set.</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.160" spread="0.0766"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" spread="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.66" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.630" spread="0.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.27" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.51" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="0.529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.58" spread="4.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Pre-dose at Day 8, Day 15, and Day 29</time_frame>
        <population>PK set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>PK set.</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-121: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.258" spread="0.0834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.348" spread="0.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-121: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.323" spread="0.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="0.543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="0.927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread="0.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.11" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.76" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.873" spread="0.367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.998" spread="0.367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.916" spread="0.586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="0.427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="0.619"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.823" spread="0.573"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.819" spread="0.412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.990" spread="0.632"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Absolute Change in Sweat Chloride (SwCl) Concentrations</title>
        <description>Sweat samples were collected using an approved collection device.</description>
        <time_frame>From Baseline Through Day 29</time_frame>
        <population>Full analysis set (FAS) included all randomized participants who carry the intended CF transmembrane conductance regulator protein (CFTR) allele mutation and have received at least 1 dose of study drug in the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: Placebo</title>
            <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Absolute Change in Sweat Chloride (SwCl) Concentrations</title>
          <description>Sweat samples were collected using an approved collection device.</description>
          <population>Full analysis set (FAS) included all randomized participants who carry the intended CF transmembrane conductance regulator protein (CFTR) allele mutation and have received at least 1 dose of study drug in the treatment period.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="-19.7" upper_limit="24.9"/>
                    <measurement group_id="O2" value="-47.7" lower_limit="-58.2" upper_limit="-37.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)</title>
        <description>FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.</description>
        <time_frame>From Baseline Through Day 29</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: Placebo</title>
            <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-121/TEZ/IVA</title>
            <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)</title>
          <description>FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.</description>
          <population>FAS.</population>
          <units>percentage points</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-12.9" upper_limit="8.9"/>
                    <measurement group_id="O2" value="8.3" lower_limit="2.8" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 Through Safety Follow-up (up to Day 15 for Part A [except Cohorts A3 and A9], up to Day 26 for Cohort A3, up to Day 34 for Cohort A9, up to Day 20 for Part B, up to Day 24 for Part C and up to Week 9 for Part D)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part A: Pooled Placebo (Cohorts A1-5; Except A3)</title>
          <description>Participants received single dose of placebo matched to VX-121.</description>
        </group>
        <group group_id="E2">
          <title>Part A: VX-121 (Cohort A1)</title>
          <description>Participants received single dose of VX-121 10 mg.</description>
        </group>
        <group group_id="E3">
          <title>Part A: VX-121 (Cohort A2)</title>
          <description>Participants received single dose of VX-121 20 mg.</description>
        </group>
        <group group_id="E4">
          <title>Part A: VX-121 (Cohort A3)</title>
          <description>Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.</description>
        </group>
        <group group_id="E5">
          <title>Part A: VX-121 (Cohort A4)</title>
          <description>Participants received single dose of VX-121 40 mg.</description>
        </group>
        <group group_id="E6">
          <title>Part A: VX-121 (Cohort A5)</title>
          <description>Participants received single dose of VX-121 60 mg.</description>
        </group>
        <group group_id="E7">
          <title>Part A: VX-121 (Cohort A9)</title>
          <description>Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.</description>
        </group>
        <group group_id="E8">
          <title>Part B: Pooled Placebo (Cohorts B1-4)</title>
          <description>Participants received placebo matched to VX-121 for 10 days.</description>
        </group>
        <group group_id="E9">
          <title>Part B: VX-121 (Cohort B1)</title>
          <description>Participants received VX-121 10 mg qd for 10 days.</description>
        </group>
        <group group_id="E10">
          <title>Part B: VX-121 (Cohort B2)</title>
          <description>Participants received VX-121 20 mg qd for 10 days.</description>
        </group>
        <group group_id="E11">
          <title>Part B: VX-121 (Cohort B3)</title>
          <description>Participants received VX-121 40 mg qd for 10 days.</description>
        </group>
        <group group_id="E12">
          <title>Part B: VX-121 (Cohort B4)</title>
          <description>Participants received VX-121 60 mg qd for 10 days.</description>
        </group>
        <group group_id="E13">
          <title>Part C: Pooled Placebo (Cohorts C1-3)</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA for 14 days.</description>
        </group>
        <group group_id="E14">
          <title>Part C: VX-121 (Cohort C1)</title>
          <description>Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="E15">
          <title>Part C: VX-121 (Cohort C2)</title>
          <description>Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="E16">
          <title>Part C: VX-121 (Cohort C3)</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.</description>
        </group>
        <group group_id="E17">
          <title>Part D: Placebo</title>
          <description>Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.</description>
        </group>
        <group group_id="E18">
          <title>Part D: VX-121/TEZ/IVA</title>
          <description>Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective pulmonary exacerbation of cystic fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="7" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Defaecation urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective pulmonary exacerbation of cystic fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Faecal volume decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Influenza A virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Ophthalmoplegic migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Sputum increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Vertex Pharmaceuticals Incorporated</organization>
      <phone>617-341-6777</phone>
      <email>medicalinfo@vrtx.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/NCT03768089
org study id: VX17-121-001
secondary id: 2018-000126-55
nct id: NCT03768089
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy
      subjects and in subjects with cystic fibrosis (CF).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From Day 1 Through Safety Follow-up (up to Day 15 for Part A [except Cohorts A3 and A9], up to Day 26 for Cohort A3, up to Day 34 for Cohort A9, up to Day 20 for Part B, up to Day 24 for Part C and up to Week 9 for Part D)
measure: Part A: Maximum Observed Concentration (Cmax) of VX-121
time frame: Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose
measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121
time frame: Cohorts A1-5 (Except A3): Pre-dose up to 240 hours post-dose; Cohorts A3 and A9: Pre-dose up to 168 hours post-dose
measure: Part B: Maximum Observed Concentration (Cmax) of VX-121
time frame: Day 1, Day 5, and Day 10
measure: Part B: Area Under the Concentration Versus Time Curve During the Dosing Interval (AUCtau) of VX-121
time frame: Day 1, Day 5, and Day 10
measure: Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121
time frame: Pre-dose at Day 5 and Day 10
measure: Part C: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and, IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Day 1, Day 7, and Day 14
measure: Part C: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Day 1, Day 7, and Day 14
measure: Part C: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Pre-dose at Day 7 and Day 14
measure: Part D: Maximum Observed Concentration (Cmax) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Day 1 and Day 15
measure: Part D: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-last]) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Day 1 and Day 15
measure: Part D: Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ and Its Metabolites (M1-TEZ and M2-TEZ) and IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Pre-dose at Day 8, Day 15, and Day 29
measure: Part D: Absolute Change in Sweat Chloride (SwCl) Concentrations
time frame: From Baseline Through Day 29
description: Sweat samples were collected using an approved collection device.
measure: Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
time frame: From Baseline Through Day 29
description: FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
arm group label: Part A: Pooled Placebo (Cohorts A1-5; Except A3)
arm group type: Placebo Comparator
description: Participants received single dose of placebo matched to VX-121.
arm group label: Part A: VX-121 (Cohort A1)
arm group type: Experimental
description: Participants received single dose of VX-121 10 milligrams (mg).
arm group label: Part A: VX-121 (Cohort A2)
arm group type: Experimental
description: Participants received single dose of VX-121 20 mg.
arm group label: Part A: VX-121 (Cohort A3)
arm group type: Experimental
description: Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk.
arm group label: Part A: VX-121 (Cohort A4)
arm group type: Experimental
description: Participants received single dose of VX-121 40 mg.
arm group label: Part A: VX-121 (Cohort A5)
arm group type: Experimental
description: Participants received single dose of VX-121 60 mg.
arm group label: Part A: VX-121 (Cohort A9)
arm group type: Experimental
description: Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17.
arm group label: Part B: Pooled Placebo (Cohorts B1-4)
arm group type: Placebo Comparator
description: Participants received placebo matched to VX-121 for 10 days.
arm group label: Part B: VX-121 (Cohort B1)
arm group type: Experimental
description: Participants received VX-121 10 mg once daily (qd) for 10 days.
arm group label: Part B: VX-121 (Cohort B2)
arm group type: Experimental
description: Participants received VX-121 20 mg qd for 10 days.
arm group label: Part B: VX-121 (Cohort B3)
arm group type: Experimental
description: Participants received VX-121 40 mg qd for 10 days.
arm group label: Part B: VX-121 (Cohort B4)
arm group type: Experimental
description: Participants received VX-121 60 mg qd for 10 days.
arm group label: Part C: Pooled Placebo (Cohorts C1-3)
arm group type: Placebo Comparator
description: Participants received placebo matched to VX-121/TEZ/IVA for 14 days.
arm group label: Part C: VX-121 (Cohort C1)
arm group type: Experimental
description: Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) for 14 days.
arm group label: Part C: VX-121 (Cohort C2)
arm group type: Experimental
description: Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.
arm group label: Part C: VX-121 (Cohort C3)
arm group type: Experimental
description: Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days.
arm group label: Part D: Placebo
arm group type: Placebo Comparator
description: Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks.
arm group label: Part D: VX-121/TEZ/IVA
arm group type: Experimental
description: Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks.
intervention type: Drug
intervention name: Placebo (matched to VX-121 suspension)
description: Placebo matched to VX-121 suspension for oral administration.
arm group label: Part A: Pooled Placebo (Cohorts A1-5; Except A3)
arm group label: Part A: VX-121 (Cohort A3)
arm group label: Part B: Pooled Placebo (Cohorts B1-4)
arm group label: Part C: Pooled Placebo (Cohorts C1-3)
intervention type: Drug
intervention name: VX-121 (Suspension)
description: Suspension for oral administration.
arm group label: Part A: VX-121 (Cohort A1)
arm group label: Part A: VX-121 (Cohort A2)
arm group label: Part A: VX-121 (Cohort A3)
arm group label: Part A: VX-121 (Cohort A4)
arm group label: Part A: VX-121 (Cohort A5)
arm group label: Part A: VX-121 (Cohort A9)
arm group label: Part B: VX-121 (Cohort B1)
arm group label: Part B: VX-121 (Cohort B2)
arm group label: Part B: VX-121 (Cohort B3)
arm group label: Part B: VX-121 (Cohort B4)
arm group label: Part C: VX-121 (Cohort C1)
arm group label: Part C: VX-121 (Cohort C2)
arm group label: Part C: VX-121 (Cohort C3)
intervention type: Drug
intervention name: TEZ/IVA
description: Fixed-dose combination tablet for oral administration.
arm group label: Part C: VX-121 (Cohort C1)
arm group label: Part C: VX-121 (Cohort C2)
arm group label: Part C: VX-121 (Cohort C3)
arm group label: Part D: VX-121/TEZ/IVA
other name: VX-661/VX-770
other name: tezacaftor/ivacaftor
intervention type: Drug
intervention name: IVA
description: Tablet for oral administration.
arm group label: Part C: VX-121 (Cohort C1)
arm group label: Part C: VX-121 (Cohort C2)
arm group label: Part C: VX-121 (Cohort C3)
arm group label: Part D: VX-121/TEZ/IVA
other name: VX-770
other name: ivacaftor
intervention type: Drug
intervention name: Placebo (matched to TEZ/IVA)
description: Placebo matched to TEZ/IVA for oral administration.
arm group label: Part C: Pooled Placebo (Cohorts C1-3)
arm group label: Part D: Placebo
intervention type: Drug
intervention name: Placebo (matched to IVA)
description: Placebo matched to IVA for oral administration.
arm group label: Part C: Pooled Placebo (Cohorts C1-3)
arm group label: Part D: Placebo
intervention type: Drug
intervention name: VX-121 (Tablet)
description: Tablet for oral administration.
arm group label: Part A: VX-121 (Cohort A9)
arm group label: Part D: VX-121/TEZ/IVA
intervention type: Drug
intervention name: Placebo (matched to VX-121 tablet)
description: Placebo matched to VX-121 tablet for oral administration.
arm group label: Part D: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Ivacaftor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 