<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/NCT03227471</url>
  </required_header>
  <id_info>
    <org_study_id>VX16-445-001</org_study_id>
    <secondary_id>2017-000797-11</secondary_id>
    <nct_id>NCT03227471</nct_id>
  </id_info>
  <brief_title>A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis</brief_title>
  <official_title>A Phase 1/2 Study of VX-445 in Healthy Subjects and 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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts.&#xD;
      Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in&#xD;
      subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF&#xD;
      transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for&#xD;
      the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ,&#xD;
      IVA, or TEZ/IVA (F/MF genotypes).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">March 27, 2018</completion_date>
  <primary_completion_date type="Actual">March 27, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose of study drug in treatment period up to safety follow-up (up to 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)</time_frame>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_outcome>
    <measure>Part E: 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>
  </primary_outcome>
  <primary_outcome>
    <measure>Part F: 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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A: Maximum Observed Concentration (Cmax) of VX-445</measure>
    <time_frame>Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</measure>
    <time_frame>Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Maximum Observed Concentration (Cmax) of VX-445</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1 and Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1 and Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445</measure>
    <time_frame>Pre-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</measure>
    <time_frame>Pre-dose on Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)</measure>
    <time_frame>Pre-dose on Day 7 and Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)</measure>
    <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)</measure>
    <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561</measure>
    <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Absolute Change in Sweat Chloride Concentration</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 E: Absolute Change in Sweat Chloride Concentration</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 F: Absolute Change in Sweat Chloride Concentration</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: Relative 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>
  <secondary_outcome>
    <measure>Part E: Relative 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>
  <secondary_outcome>
    <measure>Part F: Relative 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>
  <secondary_outcome>
    <measure>Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</measure>
    <time_frame>From Baseline through Day 29</time_frame>
    <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</measure>
    <time_frame>From Baseline through Day 29</time_frame>
    <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</measure>
    <time_frame>From Baseline through Day 29</time_frame>
    <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
  </secondary_outcome>
  <number_of_arms>15</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Part A: Pooled Placebo (Except Cohort A7)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-445 (Except Cohort A7)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: VX-445 (Cohort A7)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Pooled Placebo (Cohort B1 to B4)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: VX-445 (Cohort B1 to B4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants without CF who received VX-445 tablet qd for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: Pooled Placebo (Cohort C1 to C3)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) qd in the morning and placebo matched to IVA in the evening for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 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 with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA qd in the evening for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Medium Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part E: TEZ/IVA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part E: VX-445/TEZ/IVA TC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part F: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part F: VX-445/TEZ/VX-561 TC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVA</intervention_name>
    <description>IVA tablet for oral administration</description>
    <arm_group_label>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - High Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Low Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Medium Dose</arm_group_label>
    <arm_group_label>Part E: VX-445/TEZ/IVA TC</arm_group_label>
    <other_name>VX-770</other_name>
    <other_name>ivacaftor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TEZ/IVA</intervention_name>
    <description>TEZ/IVA fixed-dose combination for oral administration.</description>
    <arm_group_label>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - High Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Low Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Medium Dose</arm_group_label>
    <arm_group_label>Part E: TEZ/IVA</arm_group_label>
    <arm_group_label>Part E: VX-445/TEZ/IVA TC</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>VX-445</intervention_name>
    <description>VX-445 tablet for oral administration.</description>
    <arm_group_label>Part A: VX-445 (Cohort A7)</arm_group_label>
    <arm_group_label>Part A: VX-445 (Except Cohort A7)</arm_group_label>
    <arm_group_label>Part B: VX-445 (Cohort B1 to B4)</arm_group_label>
    <arm_group_label>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - High Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Low Dose</arm_group_label>
    <arm_group_label>Part D: VX-445/TEZ/IVA TC - Medium Dose</arm_group_label>
    <arm_group_label>Part E: VX-445/TEZ/IVA TC</arm_group_label>
    <arm_group_label>Part F: VX-445/TEZ/VX-561 TC</arm_group_label>
    <other_name>ELX</other_name>
    <other_name>elexacaftor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matched Placebo</intervention_name>
    <description>Matched placebo.</description>
    <arm_group_label>Part A: Pooled Placebo (Except Cohort A7)</arm_group_label>
    <arm_group_label>Part B: Pooled Placebo (Cohort B1 to B4)</arm_group_label>
    <arm_group_label>Part C: Pooled Placebo (Cohort C1 to C3)</arm_group_label>
    <arm_group_label>Part D: Placebo</arm_group_label>
    <arm_group_label>Part F: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TEZ</intervention_name>
    <description>Tablet for oral administration.</description>
    <arm_group_label>Part F: VX-445/TEZ/VX-561 TC</arm_group_label>
    <other_name>VX-661</other_name>
    <other_name>tezacaftor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-561</intervention_name>
    <description>Tablet for oral administration.</description>
    <arm_group_label>Part F: VX-445/TEZ/VX-561 TC</arm_group_label>
    <other_name>CTP-656</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-445</intervention_name>
    <description>VX-445 IV injection</description>
    <arm_group_label>Part A: VX-445 (Cohort A7)</arm_group_label>
    <other_name>ELX</other_name>
    <other_name>elexacaftor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        Parts A, B, and C:&#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 &gt;50 kg&#xD;
&#xD;
        Parts D, E, and F:&#xD;
&#xD;
          -  Body weight ≥35 kg.&#xD;
&#xD;
          -  Subjects must have an eligible CFTR genotype:&#xD;
&#xD;
               -  Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)&#xD;
&#xD;
               -  Part E: Homozygous for F508del (F/F)&#xD;
&#xD;
          -  FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        Parts A, B, and C:&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption.&#xD;
&#xD;
          -  History of febrile illness within 14 days before the first study drug dose.&#xD;
&#xD;
          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
        Parts D, E, and F:&#xD;
&#xD;
          -  History of clinically significant cirrhosis with or without portal hypertension.&#xD;
&#xD;
          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
          -  Lung infection with organisms associated with a more rapid decline in pulmonary&#xD;
             status.&#xD;
&#xD;
          -  History of solid organ or hematological transplantation.&#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>Banner University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Children's Healthcare</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(Kaiser Permanente) Oakland Medical Center</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>96411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Florida Pulmonary Group</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital Cardiac and Lung Transplant Clinic</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Specialty Services at North Druid Hills</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Clinical Research Unit Inc., Evansville Clinic [Parts A, B, C only]</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harper University Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico School of Medicine</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Health Office of Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center/Rainbow Babies and Children's Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Children's Chest Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Center</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital Melbourne</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Adult Hospital</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Centre</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>Radboud UMC</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_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>November 9, 2021</results_first_submitted>
  <results_first_submitted_qc>December 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2022</results_first_posted>
  <disposition_first_submitted>March 26, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>December 16, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 18, 2022</disposition_first_posted>
  <last_update_submitted>December 16, 2021</last_update_submitted>
  <last_update_submitted_qc>December 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>
    <mesh_term>Elexacaftor</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>August 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03227471/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>October 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03227471/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study included 6 parts: Parts A, B, and C were conducted in healthy adult participants; Part D, E, and F were conducted in adult cystic fibrosis (CF) participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: Pooled Placebo (Except Cohort A7)</title>
          <description>Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.</description>
        </group>
        <group group_id="P2">
          <title>Part A: VX-445 (Except Cohort A7)</title>
          <description>Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.</description>
        </group>
        <group group_id="P3">
          <title>Part A: VX-445 (Cohort A7)</title>
          <description>Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.</description>
        </group>
        <group group_id="P4">
          <title>Part B: Pooled Placebo (Cohort B1 to B4)</title>
          <description>Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.</description>
        </group>
        <group group_id="P5">
          <title>Part B: VX-445 (Cohort B1 to B4)</title>
          <description>Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).</description>
        </group>
        <group group_id="P6">
          <title>Part C: Pooled Placebo (Cohort C1 to C3)</title>
          <description>Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.</description>
        </group>
        <group group_id="P7">
          <title>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</title>
          <description>Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.</description>
        </group>
        <group group_id="P8">
          <title>Part D: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P9">
          <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P10">
          <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P11">
          <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P12">
          <title>Part E: TEZ/IVA</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P13">
          <title>Part E: VX-445/TEZ/IVA TC</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P14">
          <title>Part F: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="P15">
          <title>Part F: VX-445/TEZ/VX-561 TC</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="25"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="12"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="22"/>
                <participants group_id="P11" count="21"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="21"/>
                <participants group_id="P14" count="8"/>
                <participants group_id="P15" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="25"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="12"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="22"/>
                <participants group_id="P11" count="21"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="21"/>
                <participants group_id="P14" count="8"/>
                <participants group_id="P15" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="24"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="12"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="22"/>
                <participants group_id="P11" count="21"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="20"/>
                <participants group_id="P14" count="8"/>
                <participants group_id="P15" count="21"/>
              </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="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part A: Pooled Placebo (Except Cohort A7)</title>
          <description>Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.</description>
        </group>
        <group group_id="B2">
          <title>Part A: VX-445 (Except Cohort A7)</title>
          <description>Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.</description>
        </group>
        <group group_id="B3">
          <title>Part A: VX-445 (Cohort A7)</title>
          <description>Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.</description>
        </group>
        <group group_id="B4">
          <title>Part B: Pooled Placebo (Cohort B1 to B4)</title>
          <description>Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.</description>
        </group>
        <group group_id="B5">
          <title>Part B: VX-445 (Cohort B1 to B4)</title>
          <description>Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).</description>
        </group>
        <group group_id="B6">
          <title>Part C: Pooled Placebo (Cohort C1 to C3)</title>
          <description>Participants without CF who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 14 days.</description>
        </group>
        <group group_id="B7">
          <title>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</title>
          <description>Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.</description>
        </group>
        <group group_id="B8">
          <title>Part D: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B9">
          <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B10">
          <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B11">
          <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B12">
          <title>Part E: TEZ/IVA</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B13">
          <title>Part E: VX-445/TEZ/IVA TC</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B14">
          <title>Part F: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B15">
          <title>Part F: VX-445/TEZ/VX-561 TC</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="B16">
          <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="9"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="25"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="17"/>
            <count group_id="B8" value="12"/>
            <count group_id="B9" value="10"/>
            <count group_id="B10" value="22"/>
            <count group_id="B11" value="21"/>
            <count group_id="B12" value="7"/>
            <count group_id="B13" value="21"/>
            <count group_id="B14" value="8"/>
            <count group_id="B15" value="21"/>
            <count group_id="B16" value="224"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="22"/>
                    <measurement group_id="B11" value="21"/>
                    <measurement group_id="B12" value="7"/>
                    <measurement group_id="B13" value="21"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="21"/>
                    <measurement group_id="B16" value="224"/>
                  </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_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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="11"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="9"/>
                    <measurement group_id="B14" value="5"/>
                    <measurement group_id="B15" value="10"/>
                    <measurement group_id="B16" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="15"/>
                    <measurement group_id="B11" value="10"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="12"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="11"/>
                    <measurement group_id="B16" value="166"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="24"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="22"/>
                    <measurement group_id="B11" value="20"/>
                    <measurement group_id="B12" value="7"/>
                    <measurement group_id="B13" value="20"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="20"/>
                    <measurement group_id="B16" value="210"/>
                  </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="1"/>
                    <measurement group_id="B16" value="1"/>
                  </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="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_list>
                </category>
                <category>
                  <title>Asian</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="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="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="2"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="22"/>
                    <measurement group_id="B11" value="21"/>
                    <measurement group_id="B12" value="7"/>
                    <measurement group_id="B13" value="21"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="20"/>
                    <measurement group_id="B16" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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_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="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <time_frame>From first dose of study drug in treatment period up to safety follow-up (up to 28 days)</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 (Except Cohort A7)</title>
            <description>Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-445 (Except Cohort A7)</title>
            <description>Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-445 (Cohort A7)</title>
            <description>Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.</description>
          </group>
          <group group_id="O4">
            <title>Part B: Pooled Placebo (Cohort B1 to B4)</title>
            <description>Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.</description>
          </group>
          <group group_id="O5">
            <title>Part B: VX-445 (Cohort B1 to B4)</title>
            <description>Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).</description>
          </group>
          <group group_id="O6">
            <title>Part C: Pooled Placebo (Cohort C1 to C3)</title>
            <description>Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) once daily in the morning and placebo matched to IVA in the evening for 14 days.</description>
          </group>
          <group group_id="O7">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</title>
            <description>Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A, B and C: Number of Participants With Adverse Events (AEs) 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>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="5"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <time_frame>From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)</time_frame>
        <population>The Safety Set will include all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445/TEZ/IVA TC for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Part F: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O6">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <population>The Safety Set will include all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</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>The full analysis set (FAS) included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug in the TC treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</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>The full analysis set (FAS) included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug in the TC treatment period.</population>
          <units>percentage points</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="2.0"/>
                    <measurement group_id="O2" value="11.1" spread="2.1"/>
                    <measurement group_id="O3" value="7.9" spread="1.4"/>
                    <measurement group_id="O4" value="13.8" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9943</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part E: 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 E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: 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>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="2.8"/>
                    <measurement group_id="O2" value="11.0" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8869</p_value>
            <p_value_desc>P value within treatment.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part F: 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 F: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg/TEZ 100 mg/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: 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>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="2.6"/>
                    <measurement group_id="O2" value="11.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6407</p_value>
            <p_value_desc>P value within treatment</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Maximum Observed Concentration (Cmax) of VX-445</title>
        <time_frame>Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose</time_frame>
        <population>The Pharmacokinetic 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-445 (Cohort A1)</title>
            <description>Participants received single dose of VX-445 20 mg tablet in Cohort A1.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-445 (Cohort A2)</title>
            <description>Participants received single dose of VX-445 60 mg tablet in Cohort A2.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-445 (Cohort A3)</title>
            <description>Participants received single dose of VX-445 120 mg tablet in Cohort A3.</description>
          </group>
          <group group_id="O4">
            <title>Part A: VX-445 (Cohort A4)</title>
            <description>Participants received single dose of VX-445 240 mg tablet in Cohort A4.</description>
          </group>
          <group group_id="O5">
            <title>Part A: VX-445 (Cohort A5)</title>
            <description>Participants received single dose of VX-445 360 mg tablet in Cohort A5.</description>
          </group>
          <group group_id="O6">
            <title>Part A: VX-445 (Cohort A7-Fasted)</title>
            <description>Participants received single dose of VX-445 100 mg tablet on Day 1 in fasted state in Cohort A7.</description>
          </group>
          <group group_id="O7">
            <title>Part A: VX-445 (Cohort A7-Fed)</title>
            <description>Participants received single dose of VX-445 100 mg tablet on Day 7 in fed state in Cohort A7.</description>
          </group>
          <group group_id="O8">
            <title>Part A: VX-445 (Cohort A7-IV)</title>
            <description>Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Maximum Observed Concentration (Cmax) of VX-445</title>
          <population>The Pharmacokinetic 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</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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 group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.398" spread="23.0"/>
                    <measurement group_id="O2" value="0.989" spread="35.1"/>
                    <measurement group_id="O3" value="2.52" spread="13.0"/>
                    <measurement group_id="O4" value="4.56" spread="28.2"/>
                    <measurement group_id="O5" value="7.07" spread="19.1"/>
                    <measurement group_id="O6" value="0.486" spread="27.4"/>
                    <measurement group_id="O7" value="1.76" spread="14.6"/>
                    <measurement group_id="O8" value="0.740" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</title>
        <time_frame>Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose</time_frame>
        <population>The Pharmacokinetic Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: VX-445 (Cohort A1)</title>
            <description>Participants received single dose of VX-445 20 mg tablet in Cohort A1.</description>
          </group>
          <group group_id="O2">
            <title>Part A: VX-445 (Cohort A2)</title>
            <description>Participants received single dose of VX-445 60 mg tablet in Cohort A2.</description>
          </group>
          <group group_id="O3">
            <title>Part A: VX-445 (Cohort A3)</title>
            <description>Participants received single dose of VX-445 120 mg tablet in Cohort A3.</description>
          </group>
          <group group_id="O4">
            <title>Part A: VX-445 (Cohort A4)</title>
            <description>Participants received single dose of VX-445 240 mg tablet in Cohort A4.</description>
          </group>
          <group group_id="O5">
            <title>Part A: VX-445 (Cohort A5)</title>
            <description>Participants received single dose of VX-445 360 mg tablet in Cohort A5.</description>
          </group>
          <group group_id="O6">
            <title>Part A: VX-445 (Cohort A7-Fasted)</title>
            <description>Participants received single dose of VX-445 100 mg tablet on Day 1 in fasted state in Cohort A7.</description>
          </group>
          <group group_id="O7">
            <title>Part A: VX-445 (Cohort A7-Fed)</title>
            <description>Participants received single dose of VX-445 100 mg tablet on Day 7 in fed state in Cohort A7.</description>
          </group>
          <group group_id="O8">
            <title>Part A: VX-445 (Cohort A7-IV)</title>
            <description>Participants received single IV injection of VX-445 20 mg on Day 13 in fed state in Cohort A7.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</title>
          <population>The Pharmacokinetic Set.</population>
          <units>microgram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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 group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="34.2"/>
                    <measurement group_id="O2" value="30.8" spread="21.2"/>
                    <measurement group_id="O3" value="87.1" spread="39.9"/>
                    <measurement group_id="O4" value="125" spread="34.2"/>
                    <measurement group_id="O5" value="286" spread="9.30"/>
                    <measurement group_id="O6" value="21.8" spread="31.5"/>
                    <measurement group_id="O7" value="55.1" spread="14.9"/>
                    <measurement group_id="O8" value="13.6" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Maximum Observed Concentration (Cmax) of VX-445</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1 and Day 10</time_frame>
        <population>The Pharmacokinetic Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-445 (Cohort B1)</title>
            <description>Participants received VX-445 60 mg tablet once daily for 10 days in Cohort B1.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-445 (Cohort B2)</title>
            <description>Participants received VX-445 120 mg tablet once daily for 10 days in Cohort B2.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-445 (Cohort B3)</title>
            <description>Participants received VX-445 240 mg tablet once daily for 10 days in Cohort B3.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-445 (Cohort B4)</title>
            <description>Participants received VX-445 340 mg tablet once daily for 10 days in Cohort B4.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Maximum Observed Concentration (Cmax) of VX-445</title>
          <population>The Pharmacokinetic Set.</population>
          <units>microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="19.9"/>
                    <measurement group_id="O2" value="2.82" spread="25.5"/>
                    <measurement group_id="O3" value="3.47" spread="52.9"/>
                    <measurement group_id="O4" value="9.56" spread="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="15"/>
                    <measurement group_id="O2" value="5.83" spread="28.1"/>
                    <measurement group_id="O3" value="11.4" spread="27.2"/>
                    <measurement group_id="O4" value="18.2" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1 and Day 10</time_frame>
        <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signifies those participants who were evaluated for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-445 (Cohort B1)</title>
            <description>Participants received VX-445 60 mg tablet once daily for 10 days in Cohort B1.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-445 (Cohort B2)</title>
            <description>Participants received VX-445 120 mg tablet once daily for 10 days in Cohort B2.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-445 (Cohort B3)</title>
            <description>Participants received VX-445 240 mg tablet once daily for 10 days in Cohort B3.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-445 (Cohort B4)</title>
            <description>Participants received VX-445 340 mg tablet once daily for 10 days in Cohort B4.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445</title>
          <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signifies those participants who were evaluated for this outcome measure at specified time points.</population>
          <units>microgram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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="17.9" spread="20.0"/>
                    <measurement group_id="O2" value="42.2" spread="19.5"/>
                    <measurement group_id="O3" value="57.9" spread="42.8"/>
                    <measurement group_id="O4" value="119" spread="27.5"/>
                  </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="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.4" spread="21.8"/>
                    <measurement group_id="O2" value="183" spread="32.7"/>
                    <measurement group_id="O3" value="452" spread="41.5"/>
                    <measurement group_id="O4" value="692" spread="47.6"/>
                  </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-445</title>
        <time_frame>Pre-dose on Day 10</time_frame>
        <population>The Pharmacokinetic Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: VX-445 (Cohort B1)</title>
            <description>Participants received VX-445 60 mg tablet once daily for 10 days in Cohort B1.</description>
          </group>
          <group group_id="O2">
            <title>Part B: VX-445 (Cohort B2)</title>
            <description>Participants received VX-445 120 mg tablet once daily for 10 days in Cohort B2.</description>
          </group>
          <group group_id="O3">
            <title>Part B: VX-445 (Cohort B3)</title>
            <description>Participants received VX-445 240 mg tablet once daily for 10 days in Cohort B3.</description>
          </group>
          <group group_id="O4">
            <title>Part B: VX-445 (Cohort B4)</title>
            <description>Participants received VX-445 340 mg tablet once daily for 10 days in Cohort B4.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445</title>
          <population>The Pharmacokinetic Set.</population>
          <units>microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" spread="24.5"/>
                    <measurement group_id="O2" value="2.81" spread="33.2"/>
                    <measurement group_id="O3" value="7.10" spread="30.1"/>
                    <measurement group_id="O4" value="11.5" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
          <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
          <units>microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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-445: Day 1</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="3.04" spread="23.2"/>
                    <measurement group_id="O2" value="4.86" spread="25.4"/>
                    <measurement group_id="O3" value="1.72" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: 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="8.29" spread="31.9"/>
                    <measurement group_id="O2" value="10.3" spread="18.4"/>
                    <measurement group_id="O3" value="3.58" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <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="8.71" spread="9.65"/>
                    <measurement group_id="O2" value="14.0" spread="19.2"/>
                    <measurement group_id="O3" value="4.73" spread="15.9"/>
                  </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="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="3.81" spread="16.4"/>
                    <measurement group_id="O2" value="5.67" spread="17.2"/>
                    <measurement group_id="O3" value="5.38" spread="19.2"/>
                  </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="7.09" spread="19.4"/>
                    <measurement group_id="O2" value="8.29" spread="13.6"/>
                    <measurement group_id="O3" value="7.01" spread="14.7"/>
                  </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="4"/>
                    <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="8.11" spread="21.2"/>
                    <measurement group_id="O2" value="9.07" spread="7.60"/>
                    <measurement group_id="O3" value="8.60" spread="12.8"/>
                  </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="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="0.929" spread="35"/>
                    <measurement group_id="O2" value="0.988" spread="31.7"/>
                    <measurement group_id="O3" value="1.30" spread="17.3"/>
                  </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="4.34" spread="28.7"/>
                    <measurement group_id="O2" value="5.19" spread="16.8"/>
                    <measurement group_id="O3" value="5.86" spread="11.3"/>
                  </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="4"/>
                    <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="5.77" spread="24.6"/>
                    <measurement group_id="O2" value="6.79" spread="14.9"/>
                    <measurement group_id="O3" value="7.54" spread="11.8"/>
                  </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="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="0.553" spread="47.0"/>
                    <measurement group_id="O2" value="0.667" spread="39.6"/>
                    <measurement group_id="O3" value="0.716" spread="17.0"/>
                  </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="4.72" spread="30.3"/>
                    <measurement group_id="O2" value="6.41" spread="33.2"/>
                    <measurement group_id="O3" value="5.46" spread="29.4"/>
                  </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="4"/>
                    <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="7.69" spread="23.7"/>
                    <measurement group_id="O2" value="10.1" spread="24.2"/>
                    <measurement group_id="O3" value="7.93" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
          <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
          <units>microgram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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-445: Day 1</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="48.6" spread="22.7"/>
                    <measurement group_id="O2" value="72.5" spread="20.7"/>
                    <measurement group_id="O3" value="26.4" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: 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="156" spread="37.1"/>
                    <measurement group_id="O2" value="177" spread="30.0"/>
                    <measurement group_id="O3" value="65.4" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <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="345" spread="30.7"/>
                    <measurement group_id="O2" value="506" spread="31.5"/>
                    <measurement group_id="O3" value="183" spread="18.8"/>
                  </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="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="41.4" spread="27.5"/>
                    <measurement group_id="O2" value="43.8" spread="9.91"/>
                    <measurement group_id="O3" value="42.7" spread="20.9"/>
                  </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="103" spread="35.8"/>
                    <measurement group_id="O2" value="105" spread="16.5"/>
                    <measurement group_id="O3" value="96.9" spread="18.9"/>
                  </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="4"/>
                    <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="252" spread="35.1"/>
                    <measurement group_id="O2" value="288" spread="13.6"/>
                    <measurement group_id="O3" value="275" spread="19.5"/>
                  </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="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="17.7" spread="37.2"/>
                    <measurement group_id="O2" value="20.1" spread="35.2"/>
                    <measurement group_id="O3" value="25.5" spread="19.1"/>
                  </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="90.9" spread="29.9"/>
                    <measurement group_id="O2" value="110" spread="17.8"/>
                    <measurement group_id="O3" value="125" 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="4"/>
                    <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="380" spread="22.1"/>
                    <measurement group_id="O2" value="477" spread="16.0"/>
                    <measurement group_id="O3" value="512" spread="17.9"/>
                  </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="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="6.65" spread="48.6"/>
                    <measurement group_id="O2" value="8.19" spread="52.5"/>
                    <measurement group_id="O3" value="9.00" spread="16.6"/>
                  </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="108" spread="31.2"/>
                    <measurement group_id="O2" value="143" spread="34.1"/>
                    <measurement group_id="O3" value="123" spread="28.7"/>
                  </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="4"/>
                    <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="617" spread="23.2"/>
                    <measurement group_id="O2" value="831" spread="29.5"/>
                    <measurement group_id="O3" value="652" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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>IVA: Day 1</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="425" spread="29.8"/>
                    <measurement group_id="O2" value="461" spread="49.3"/>
                    <measurement group_id="O3" value="437" spread="9.63"/>
                  </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="1290" spread="41.1"/>
                    <measurement group_id="O2" value="1190" spread="42.4"/>
                    <measurement group_id="O3" value="1070" spread="20.0"/>
                  </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="4"/>
                    <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="1360" spread="21.9"/>
                    <measurement group_id="O2" value="1920" spread="33.7"/>
                    <measurement group_id="O3" value="1410" spread="25.5"/>
                  </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="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="1250" spread="29.9"/>
                    <measurement group_id="O2" value="1190" spread="28.1"/>
                    <measurement group_id="O3" value="1070" spread="28.6"/>
                  </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="2460" spread="26.8"/>
                    <measurement group_id="O2" value="2590" spread="28.1"/>
                    <measurement group_id="O3" value="2070" spread="23.1"/>
                  </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="4"/>
                    <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="2680" spread="19.4"/>
                    <measurement group_id="O2" value="3900" spread="21.4"/>
                    <measurement group_id="O3" value="2990" spread="28.3"/>
                  </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="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="901" spread="38.2"/>
                    <measurement group_id="O2" value="1180" spread="16.6"/>
                    <measurement group_id="O3" value="631" spread="31.1"/>
                  </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="1960" spread="38.1"/>
                    <measurement group_id="O2" value="2590" spread="7.3"/>
                    <measurement group_id="O3" value="1400" spread="29.8"/>
                  </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="4"/>
                    <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="2060" spread="30.1"/>
                    <measurement group_id="O2" value="3350" spread="17.4"/>
                    <measurement group_id="O3" value="1980" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>The Pharmacokinetic Set. Here &quot;Number analyzed&quot; signified those subjects who were evaluated at specified time points.</population>
          <units>nanogram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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>IVA: Day 1</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="6350" spread="40.9"/>
                    <measurement group_id="O2" value="6210" spread="45.5"/>
                    <measurement group_id="O3" value="5480" spread="28.5"/>
                  </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="21600" spread="65.6"/>
                    <measurement group_id="O2" value="18800" spread="50.7"/>
                    <measurement group_id="O3" value="16900" spread="28.4"/>
                  </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="4"/>
                    <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="27900" spread="48.7"/>
                    <measurement group_id="O2" value="35000" spread="44.8"/>
                    <measurement group_id="O3" value="32600" spread="40.6"/>
                  </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="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="16900" spread="38.9"/>
                    <measurement group_id="O2" value="14800" spread="32.3"/>
                    <measurement group_id="O3" value="13300" spread="21.1"/>
                  </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="47500" spread="43.6"/>
                    <measurement group_id="O2" value="46300" spread="30.6"/>
                    <measurement group_id="O3" value="36400" spread="25.9"/>
                  </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="4"/>
                    <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="75300" spread="42.7"/>
                    <measurement group_id="O2" value="97000" spread="31.3"/>
                    <measurement group_id="O3" value="86100" spread="30.2"/>
                  </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="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="11100" spread="49.9"/>
                    <measurement group_id="O2" value="14100" spread="20.3"/>
                    <measurement group_id="O3" value="9050" spread="26.1"/>
                  </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="39700" spread="38.8"/>
                    <measurement group_id="O2" value="51400" spread="13.0"/>
                    <measurement group_id="O3" value="29100" spread="36.0"/>
                  </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="4"/>
                    <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="66300" spread="44.9"/>
                    <measurement group_id="O2" value="123000" spread="23.1"/>
                    <measurement group_id="O3" value="67100" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
        <time_frame>Pre-dose on Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)</title>
          <population>The Pharmacokinetic Set.</population>
          <units>microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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-445: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.63" spread="46.8"/>
                    <measurement group_id="O2" value="5.91" spread="35.5"/>
                    <measurement group_id="O3" value="2.09" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45" spread="38.9"/>
                    <measurement group_id="O2" value="7.60" spread="29.8"/>
                    <measurement group_id="O3" value="2.92" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="48.7"/>
                    <measurement group_id="O2" value="2.77" spread="19.2"/>
                    <measurement group_id="O3" value="2.52" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.10" spread="33.4"/>
                    <measurement group_id="O2" value="3.70" spread="16.0"/>
                    <measurement group_id="O3" value="3.62" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="27.1"/>
                    <measurement group_id="O2" value="3.98" spread="16.8"/>
                    <measurement group_id="O3" value="4.71" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" spread="20.5"/>
                    <measurement group_id="O2" value="5.42" spread="16.1"/>
                    <measurement group_id="O3" value="5.52" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.06" spread="32.8"/>
                    <measurement group_id="O2" value="5.63" spread="37.5"/>
                    <measurement group_id="O3" value="4.92" spread="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2-TEZ: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.46" spread="22.5"/>
                    <measurement group_id="O2" value="8.85" spread="29.9"/>
                    <measurement group_id="O3" value="7.38" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
        <time_frame>Pre-dose on Day 7 and Day 14</time_frame>
        <population>The Pharmacokinetic Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C1)</title>
            <description>Participants received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C1 for 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C2)</title>
            <description>Participants received VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C2 for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part C: VX-445/TEZ/IVA TC (Cohort C3)</title>
            <description>Participants received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in cohort C3 for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)</title>
          <population>The Pharmacokinetic Set.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</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>IVA: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="753" spread="75"/>
                    <measurement group_id="O2" value="759" spread="45.7"/>
                    <measurement group_id="O3" value="604" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="610" spread="55.6"/>
                    <measurement group_id="O2" value="990" spread="43.4"/>
                    <measurement group_id="O3" value="881" spread="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1790" spread="43.7"/>
                    <measurement group_id="O2" value="1960" spread="21.4"/>
                    <measurement group_id="O3" value="1400" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1600" spread="46.2"/>
                    <measurement group_id="O2" value="2210" spread="19.8"/>
                    <measurement group_id="O3" value="1930" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1530" spread="31.5"/>
                    <measurement group_id="O2" value="2260" spread="11.9"/>
                    <measurement group_id="O3" value="1270" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6-IVA: Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1360" spread="49.1"/>
                    <measurement group_id="O2" value="2600" spread="18.0"/>
                    <measurement group_id="O3" value="1640" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)</title>
        <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
        <population>FAS. Here &quot;number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)</title>
          <population>FAS. Here &quot;number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
          <units>microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-445: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="0.612"/>
                    <measurement group_id="O2" value="2.15" spread="0.977"/>
                    <measurement group_id="O3" value="5.77" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="0.530"/>
                    <measurement group_id="O2" value="2.18" spread="1.26"/>
                    <measurement group_id="O3" value="5.57" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="1.26"/>
                    <measurement group_id="O2" value="1.68" spread="0.700"/>
                    <measurement group_id="O3" value="1.76" spread="0.960"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.16" spread="1.27"/>
                    <measurement group_id="O2" value="1.77" spread="0.833"/>
                    <measurement group_id="O3" value="2.22" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.46" spread="1.96"/>
                    <measurement group_id="O2" value="4.11" spread="1.47"/>
                    <measurement group_id="O3" value="4.43" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="2.04"/>
                    <measurement group_id="O2" value="4.30" spread="1.55"/>
                    <measurement group_id="O3" value="4.74" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.720" spread="0.484"/>
                    <measurement group_id="O2" value="0.665" spread="0.414"/>
                    <measurement group_id="O3" value="0.701" spread="0.593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.753" spread="0.424"/>
                    <measurement group_id="O2" value="0.704" spread="0.414"/>
                    <measurement group_id="O3" value="0.658" spread="0.386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.748"/>
                    <measurement group_id="O2" value="1.21" spread="0.666"/>
                    <measurement group_id="O3" value="1.45" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.830"/>
                    <measurement group_id="O2" value="1.20" spread="0.717"/>
                    <measurement group_id="O3" value="1.29" spread="0.797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)</title>
        <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
        <population>FAS. Here &quot;Number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)</title>
          <population>FAS. Here &quot;Number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
          <units>microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-445: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.07" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.35" spread="3.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.863"/>
                    <measurement group_id="O2" value="1.86" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="1.28"/>
                    <measurement group_id="O2" value="1.99" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.96" spread="1.76"/>
                    <measurement group_id="O2" value="4.57" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.73" spread="1.51"/>
                    <measurement group_id="O2" value="4.71" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.766" spread="0.366"/>
                    <measurement group_id="O2" value="0.659" spread="0.529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IVA: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.595" spread="0.303"/>
                    <measurement group_id="O2" value="0.798" spread="0.901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="0.470"/>
                    <measurement group_id="O2" value="1.09" spread="0.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-IVA: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.943" spread="0.431"/>
                    <measurement group_id="O2" value="1.43" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561</title>
        <time_frame>Pre-dose on Day 15 and Day 29</time_frame>
        <population>FAS. Here, &quot;Number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561</title>
          <population>FAS. Here, &quot;Number analyzed&quot; signifies those participants who were evaluated at specified time points for this outcome measure.</population>
          <units>microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VX-445: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-445: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.25" spread="2.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="0.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.99" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M1-TEZ: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.09" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-561: Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.441" spread="0.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VX-561: Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.597" spread="0.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Absolute Change in Sweat Chloride Concentration</title>
        <description>Sweat samples were collected using an approved collection device.</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 with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Absolute Change in Sweat Chloride Concentration</title>
          <description>Sweat samples were collected using an approved collection device.</description>
          <population>FAS.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="3.9"/>
                    <measurement group_id="O2" value="-38.2" spread="4.2"/>
                    <measurement group_id="O3" value="-33.2" spread="2.8"/>
                    <measurement group_id="O4" value="-39.1" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5802</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Absolute Change in Sweat Chloride Concentration</title>
        <description>Sweat samples were collected using an approved collection device.</description>
        <time_frame>From Baseline through Day 29</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Absolute Change in Sweat Chloride Concentration</title>
          <description>Sweat samples were collected using an approved collection device.</description>
          <population>FAS.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="4.9"/>
                    <measurement group_id="O2" value="-39.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8712</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Absolute Change in Sweat Chloride Concentration</title>
        <description>Sweat samples were collected using an approved collection device.</description>
        <time_frame>From Baseline through Day 29</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Absolute Change in Sweat Chloride Concentration</title>
          <description>Sweat samples were collected using an approved collection device.</description>
          <population>FAS.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="4.6"/>
                    <measurement group_id="O2" value="-33.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8359</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Relative 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 with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Relative 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>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="4.0"/>
                    <measurement group_id="O2" value="19.3" spread="4.2"/>
                    <measurement group_id="O3" value="13.8" spread="2.8"/>
                    <measurement group_id="O4" value="26.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9453</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Relative 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 E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Relative 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>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="5.0"/>
                    <measurement group_id="O2" value="19.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7849</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Relative 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 F: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Relative 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>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="4.6"/>
                    <measurement group_id="O2" value="19.9" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7356</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
        <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</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 with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
          <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
          <population>FAS.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="4.9"/>
                    <measurement group_id="O2" value="20.8" spread="5.4"/>
                    <measurement group_id="O3" value="15.4" spread="3.7"/>
                    <measurement group_id="O4" value="25.7" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3940</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>Mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
        <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
        <time_frame>From Baseline through Day 29</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TEZ/IVA</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part E: VX-445/TEZ/IVA TC</title>
            <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
          <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
          <population>FAS.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="7.1"/>
                    <measurement group_id="O2" value="20.7" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4757</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
        <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
        <time_frame>From Baseline through Day 29</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: Placebo</title>
            <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Part F: VX-445/TEZ/VX-561 TC</title>
            <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score</title>
          <description>The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.</description>
          <population>FAS.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="6.9"/>
                    <measurement group_id="O2" value="20.2" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0070</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P value within treatment. These are nominal p-values without multiplicity control.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Parts A, B and C: From first dose of study drug in treatment period up to safety follow-up (up to 28 days); Parts D, E and F: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)</time_frame>
      <desc>MedDRA version 19.1 for Parts A, B and C and MedDRA version 20.1 for Parts D, E and F.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A: Pooled Placebo (Except Cohort A7)</title>
          <description>Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.</description>
        </group>
        <group group_id="E2">
          <title>Part A: VX-445 (Except Cohort A7)</title>
          <description>Participants without CF who received single ascending dose of VX-445 tablet starting from 20 mg to 360 mg in Cohort A1 to A5.</description>
        </group>
        <group group_id="E3">
          <title>Part A: VX-445 (Cohort A7)</title>
          <description>Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg IV injection on Day 13 in fed state in Cohort A7.</description>
        </group>
        <group group_id="E4">
          <title>Part B: Pooled Placebo (Cohort B1 to B4)</title>
          <description>Participants without CF who received multiple doses of placebo matched to VX-445 qd for 10 days in Cohort B1 to B4.</description>
        </group>
        <group group_id="E5">
          <title>Part B: VX-445 (Cohort B1 to B4)</title>
          <description>Participants without CF who received VX-445 tablet once daily for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).</description>
        </group>
        <group group_id="E6">
          <title>Part C: Pooled Placebo (Cohort C1 to C3)</title>
          <description>Participants without CF who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 14 days.</description>
        </group>
        <group group_id="E7">
          <title>Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)</title>
          <description>Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.</description>
        </group>
        <group group_id="E8">
          <title>Part D: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC once daily in the morning and placebo matched to IVA in the evening for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E9">
          <title>Part D: VX-445/TEZ/IVA TC - Low Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E10">
          <title>Part D: VX-445/TEZ/IVA TC - Medium Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E11">
          <title>Part D: VX-445/TEZ/IVA TC - High Dose</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E12">
          <title>Part E: TEZ/IVA</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E13">
          <title>Part E: VX-445/TEZ/IVA TC</title>
          <description>Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E14">
          <title>Part F: Placebo</title>
          <description>Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.</description>
        </group>
        <group group_id="E15">
          <title>Part F: VX-445/TEZ/VX-561 TC</title>
          <description>Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1, 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Distal intestinal obstruction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Influenza A virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1, 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="17" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="18" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="17" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infective pulmonary exacerbation of cystic fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radiation injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Forced expiratory volume decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pulmonary function test decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sputum increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="8" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiration abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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/NCT03227471
org study id: VX16-445-001
secondary id: 2017-000797-11
nct id: NCT03227471
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts.
      Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in
      subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF
      transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for
      the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ,
      IVA, or TEZ/IVA (F/MF genotypes).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From first dose of study drug in treatment period up to safety follow-up (up to 28 days)
measure: Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
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.
measure: Part E: 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.
measure: Part F: 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.
measure: Part A: Maximum Observed Concentration (Cmax) of VX-445
time frame: Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
measure: Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
time frame: Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
measure: Part B: Maximum Observed Concentration (Cmax) of VX-445
time frame: Pre-dose to 96 hours post-dose on Day 1 and Day 10
measure: Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
time frame: Pre-dose to 96 hours post-dose on Day 1 and Day 10
measure: Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445
time frame: Pre-dose on Day 10
measure: Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
time frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
measure: Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
time frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
measure: Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
measure: Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
measure: Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
time frame: Pre-dose on Day 7 and Day 14
measure: Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
time frame: Pre-dose on Day 7 and Day 14
measure: Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
time frame: Pre-dose on Day 15 and Day 29
measure: Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
time frame: Pre-dose on Day 15 and Day 29
measure: Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
time frame: Pre-dose on Day 15 and Day 29
measure: Part D: Absolute Change in Sweat Chloride Concentration
time frame: From Baseline through Day 29
description: Sweat samples were collected using an approved collection device.
measure: Part E: Absolute Change in Sweat Chloride Concentration
time frame: From Baseline through Day 29
description: Sweat samples were collected using an approved collection device.
measure: Part F: Absolute Change in Sweat Chloride Concentration
time frame: From Baseline through Day 29
description: Sweat samples were collected using an approved collection device.
measure: Part D: Relative 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.
measure: Part E: Relative 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.
measure: Part F: Relative 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.
measure: Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
time frame: From Baseline through Day 29
description: The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
measure: Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
time frame: From Baseline through Day 29
description: The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
measure: Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
time frame: From Baseline through Day 29
description: The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
arm group label: Part A: Pooled Placebo (Except Cohort A7)
arm group type: Placebo Comparator
description: Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
arm group label: Part A: VX-445 (Except Cohort A7)
arm group type: Experimental
description: Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
arm group label: Part A: VX-445 (Cohort A7)
arm group type: Experimental
description: Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
arm group label: Part B: Pooled Placebo (Cohort B1 to B4)
arm group type: Placebo Comparator
description: Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
arm group label: Part B: VX-445 (Cohort B1 to B4)
arm group type: Experimental
description: Participants without CF who received VX-445 tablet qd for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
arm group label: Part C: Pooled Placebo (Cohort C1 to C3)
arm group type: Placebo Comparator
description: Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) qd in the morning and placebo matched to IVA in the evening for 14 days.
arm group label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
arm group type: Experimental
description: Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
arm group label: Part D: Placebo
arm group type: Placebo Comparator
description: Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA qd in the evening for 4 weeks in the TC treatment period.
arm group label: Part D: VX-445/TEZ/IVA TC - Low Dose
arm group type: Experimental
description: Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
arm group label: Part D: VX-445/TEZ/IVA TC - Medium Dose
arm group type: Experimental
description: Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
arm group label: Part D: VX-445/TEZ/IVA TC - High Dose
arm group type: Experimental
description: Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
arm group label: Part E: TEZ/IVA
arm group type: Active Comparator
description: Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
arm group label: Part E: VX-445/TEZ/IVA TC
arm group type: Experimental
description: Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
arm group label: Part F: Placebo
arm group type: Placebo Comparator
description: Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
arm group label: Part F: VX-445/TEZ/VX-561 TC
arm group type: Experimental
description: Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
intervention type: Drug
intervention name: IVA
description: IVA tablet for oral administration
arm group label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
arm group label: Part D: VX-445/TEZ/IVA TC - High Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Low Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Medium Dose
arm group label: Part E: VX-445/TEZ/IVA TC
other name: VX-770
other name: ivacaftor
intervention type: Drug
intervention name: TEZ/IVA
description: TEZ/IVA fixed-dose combination for oral administration.
arm group label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
arm group label: Part D: VX-445/TEZ/IVA TC - High Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Low Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Medium Dose
arm group label: Part E: TEZ/IVA
arm group label: Part E: VX-445/TEZ/IVA TC
other name: VX-661/VX-770
other name: tezacaftor/ivacaftor
intervention type: Drug
intervention name: VX-445
description: VX-445 tablet for oral administration.
arm group label: Part A: VX-445 (Cohort A7)
arm group label: Part A: VX-445 (Except Cohort A7)
arm group label: Part B: VX-445 (Cohort B1 to B4)
arm group label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
arm group label: Part D: VX-445/TEZ/IVA TC - High Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Low Dose
arm group label: Part D: VX-445/TEZ/IVA TC - Medium Dose
arm group label: Part E: VX-445/TEZ/IVA TC
arm group label: Part F: VX-445/TEZ/VX-561 TC
other name: ELX
other name: elexacaftor
intervention type: Drug
intervention name: Matched Placebo
description: Matched placebo.
arm group label: Part A: Pooled Placebo (Except Cohort A7)
arm group label: Part B: Pooled Placebo (Cohort B1 to B4)
arm group label: Part C: Pooled Placebo (Cohort C1 to C3)
arm group label: Part D: Placebo
arm group label: Part F: Placebo
intervention type: Drug
intervention name: TEZ
description: Tablet for oral administration.
arm group label: Part F: VX-445/TEZ/VX-561 TC
other name: VX-661
other name: tezacaftor
intervention type: Drug
intervention name: VX-561
description: Tablet for oral administration.
arm group label: Part F: VX-445/TEZ/VX-561 TC
other name: CTP-656
intervention type: Drug
intervention name: VX-445
description: VX-445 IV injection
arm group label: Part A: VX-445 (Cohort A7)
other name: ELX
other name: elexacaftor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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country: Australia
country: Belgium
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Ivacaftor
mesh term: Elexacaftor
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