<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/NCT03808298</url>
  </required_header>
  <id_info>
    <org_study_id>WP40734</org_study_id>
    <nct_id>NCT03808298</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects</brief_title>
  <official_title>A Single-Center, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled,&#xD;
      positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of&#xD;
      balovaptan on the QTc interval in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">July 13, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</measure>
    <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
    <description>Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Categorical Outliers for QTcF</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values &gt; 450 and ≤ 480 ms, &gt; 480 and ≤ 500 ms, or &gt; 500 ms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Categorical Outliers for HR</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline &gt; 25% to a HR &lt; 50 bpm; and increase in HR from pre-dose baseline &gt; 25% to a HR &gt; 100 bpm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Categorical Outliers for PR</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>PR outliers criteria is as an increase of PR from baseline &gt;25% resulting in PR &gt;200 ms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Categorical Outliers for QRS</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>QRS outlier criteria is an increase of QRS from baseline &gt;25% resulting in QRS &gt;120 ms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Changes of T-Wave Morphology</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Changes of U-Wave Presence</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
    <description>Number (percentage) of participants with treatment emergent changes of U-wave presence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Balovaptan</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of M2 Metabolite</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax M3 Metabolite</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Balovaptan</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of M2 Metabolite</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of M3 Metabolite</measure>
    <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 of Balovaptan</measure>
    <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 of M2 Metabolite</measure>
    <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 of M3 Metabolite</measure>
    <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Moxifloxacin</measure>
    <time_frame>Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Moxifloxacin</measure>
    <time_frame>Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 of Moxifloxacin</measure>
    <time_frame>Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis</measure>
    <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis</measure>
    <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis</measure>
    <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records</measure>
    <time_frame>Baseline, Day 15. (Each treatment period is 15 days.)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment Emergent Adverse Events</measure>
    <time_frame>Up to approximately 20 weeks.</time_frame>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Balovaptan therapeutic dose Treatment A</intervention_name>
    <description>Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Balovaptan supra-therapeutic dose Treatment B</intervention_name>
    <description>Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active control [moxifloxacin] on Day 2 Treatment C</intervention_name>
    <description>Day 2: A single oral dose of 400 mg moxifloxacin capsule.</description>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active control [Moxifloxacin] on Day 15 Treatment D</intervention_name>
    <description>Day 15: A single oral dose of 400 mg moxifloxacin capsule.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Balovaptan Treatment C</intervention_name>
    <description>Days 1-14: Matching placebo for balovaptan for 14 days.</description>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Balovaptan Treatment D</intervention_name>
    <description>Days 1-14: Matching placebo for balovaptan for 14 days.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Moxifloxacin Treatment A</intervention_name>
    <description>Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Moxifloxacin Treatment B</intervention_name>
    <description>Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin Treatment C</intervention_name>
    <description>Day 2: A single oral dose of 400 mg moxifloxacin capsule.</description>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Moxifloxacin Treatment C</intervention_name>
    <description>Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.</description>
    <arm_group_label>Treatment Sequence 1: A, B, C</arm_group_label>
    <arm_group_label>Treatment Sequence 2: A, C, B</arm_group_label>
    <arm_group_label>Treatment Sequence 3: B, A, C</arm_group_label>
    <arm_group_label>Treatment Sequence 4: B, C, A</arm_group_label>
    <arm_group_label>Treatment Sequence 5: C, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 6: C, B, A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Moxifloxacin Treatment D</intervention_name>
    <description>Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin Treatment D</intervention_name>
    <description>Day 15: A single oral dose of 400 mg moxifloxacin capsule.</description>
    <arm_group_label>Treatment Sequence 10: B, D, A</arm_group_label>
    <arm_group_label>Treatment Sequence 11: D, A, B</arm_group_label>
    <arm_group_label>Treatment Sequence 12: D, B, A</arm_group_label>
    <arm_group_label>Treatment Sequence 7: A, B, D</arm_group_label>
    <arm_group_label>Treatment Sequence 8: A, D, B</arm_group_label>
    <arm_group_label>Treatment Sequence 9: B, A, D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female subjects. Healthy status is defined by absence of evidence of&#xD;
             any active or chronic disease following a detailed medical and surgical history, a&#xD;
             complete physical examination including vital signs, 12-lead ECG, hematology, blood&#xD;
             chemistry, urinalysis, and serology.&#xD;
&#xD;
          -  Body Mass Index of 18 to 30 kg/m2, inclusive.&#xD;
&#xD;
          -  For women of childbearing potential: agreement to use at least 1 acceptable form of&#xD;
             contraception during the entire study and for 90 days following last dose of study&#xD;
             drug.&#xD;
&#xD;
          -  For men: vasectomized, agreement to remain abstinent or use of a condom during&#xD;
             intercourse. Must also agree to refrain from donating sperm.&#xD;
&#xD;
          -  Fluent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If female, a positive pregnancy test at screening or prior to Day 1 of any Treatment&#xD;
             Period.&#xD;
&#xD;
          -  Lactating women.&#xD;
&#xD;
          -  Any condition or disease detected during the medical interview / physical examination&#xD;
             that would render the subject unsuitable for the study, place the subject at undue&#xD;
             risk or interfere with the ability of the subject to complete the study in the opinion&#xD;
             of the Investigator or designee.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PRA International Clinical Pharmacology Center (EDS US Clinic)</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <results_first_submitted>June 2, 2020</results_first_submitted>
  <results_first_submitted_qc>July 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2020</results_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Balovaptan</mesh_term>
    <mesh_term>Norgestimate, ethinyl estradiol drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>April 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03808298/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>May 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03808298/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence A and B and Either C or D</title>
          <description>All participants received Treatment A and Treatment B and either Treatment C or Treatment D.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Positive Urine Drug Screen at Check-in</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Sequence A and B and Either C or D</title>
          <description>All participants received Treatment A and Treatment B and either Treatment C or Treatment D.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.9" spread="10.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36" lower_limit="18" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.</description>
        <time_frame>Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level of B balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14 0.75 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.89" upper_limit="1.64"/>
                    <measurement group_id="O2" value="-0.6" lower_limit="-2.35" upper_limit="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.92" upper_limit="1.67"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-1.68" upper_limit="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.25 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-1.64" upper_limit="2.01"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-1.91" upper_limit="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" lower_limit="-5.15" upper_limit="-1.52"/>
                    <measurement group_id="O2" value="-3.9" lower_limit="-5.73" upper_limit="-2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" lower_limit="-4.27" upper_limit="-0.67"/>
                    <measurement group_id="O2" value="-2.3" lower_limit="-4.13" upper_limit="-0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-3.71" upper_limit="-0.10"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-5.33" upper_limit="-1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-2.96" upper_limit="0.98"/>
                    <measurement group_id="O2" value="-2.1" lower_limit="-4.08" upper_limit="-0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" lower_limit="-11.90" upper_limit="-7.65"/>
                    <measurement group_id="O2" value="-9.6" lower_limit="-11.73" upper_limit="-7.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" lower_limit="-9.11" upper_limit="-4.05"/>
                    <measurement group_id="O2" value="-7.5" lower_limit="-10.05" upper_limit="-4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" lower_limit="-4.19" upper_limit="-0.57"/>
                    <measurement group_id="O2" value="-2.9" lower_limit="-4.67" upper_limit="-1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.47</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.99</ci_lower_limit>
            <ci_upper_limit>2.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.50</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.73</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.25</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.94</ci_lower_limit>
            <ci_upper_limit>3.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.50</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.62</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.51</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>4.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.66</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.63</ci_lower_limit>
            <ci_upper_limit>3.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.79</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.13</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.60</ci_lower_limit>
            <ci_upper_limit>4.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.03</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.</description>
        <time_frame>Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-3.36" upper_limit="-1.22"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-4.59" upper_limit="-2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-2.78" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="-2.9" lower_limit="-3.89" upper_limit="-1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-1.39" upper_limit="1.04"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-3.43" upper_limit="-0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="-0.32" upper_limit="2.52"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-2.88" upper_limit="-0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" lower_limit="-10.20" upper_limit="-6.69"/>
                    <measurement group_id="O2" value="-11.0" lower_limit="-12.72" upper_limit="-9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" lower_limit="-7.70" upper_limit="-3.32"/>
                    <measurement group_id="O2" value="-6.9" lower_limit="-9.12" upper_limit="-4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" lower_limit="-2.61" upper_limit="-0.04"/>
                    <measurement group_id="O2" value="-3.0" lower_limit="-4.26" upper_limit="-1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.86</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>2.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.74</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>2.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>2.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.99</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>3.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>2.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.18</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>4.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>2.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.46</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>4.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.84</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.62</ci_lower_limit>
            <ci_upper_limit>4.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.05</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>3.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.</description>
        <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-3.75" upper_limit="-1.68"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-4.59" upper_limit="-2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-2.51" upper_limit="-0.68"/>
                    <measurement group_id="O2" value="-2.9" lower_limit="-3.89" upper_limit="-1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-1.74" upper_limit="0.62"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-3.43" upper_limit="-0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-1.55" upper_limit="1.22"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-2.88" upper_limit="-0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" lower_limit="-10.40" upper_limit="-6.97"/>
                    <measurement group_id="O2" value="-11.0" lower_limit="-12.72" upper_limit="-9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.2" lower_limit="-8.37" upper_limit="-4.12"/>
                    <measurement group_id="O2" value="-6.9" lower_limit="-9.12" upper_limit="-4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" lower_limit="-3.85" upper_limit="-1.33"/>
                    <measurement group_id="O2" value="-3.0" lower_limit="-4.26" upper_limit="-1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.75 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-2.84" upper_limit="0.62"/>
                    <measurement group_id="O2" value="-0.6" lower_limit="-2.35" upper_limit="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-2.37" upper_limit="1.14"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-1.68" upper_limit="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.25 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-1.63" upper_limit="1.94"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-1.91" upper_limit="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" lower_limit="-5.22" upper_limit="-1.66"/>
                    <measurement group_id="O2" value="-3.9" lower_limit="-5.73" upper_limit="-2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-4.01" upper_limit="-0.49"/>
                    <measurement group_id="O2" value="-2.3" lower_limit="-4.13" upper_limit="-0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" lower_limit="-3.48" upper_limit="0.05"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-5.33" upper_limit="-1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-3.43" upper_limit="0.43"/>
                    <measurement group_id="O2" value="-2.1" lower_limit="-4.08" upper_limit="-0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" lower_limit="-11.13" upper_limit="-6.99"/>
                    <measurement group_id="O2" value="-9.6" lower_limit="-11.73" upper_limit="-7.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" lower_limit="-9.34" upper_limit="-4.41"/>
                    <measurement group_id="O2" value="-7.5" lower_limit="-10.05" upper_limit="-4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-4.51" upper_limit="-0.96"/>
                    <measurement group_id="O2" value="-2.9" lower_limit="-4.67" upper_limit="-1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.60</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.73</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>2.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.98</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>3.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.16</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.64</ci_lower_limit>
            <ci_upper_limit>3.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>2.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.45</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>4.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.82</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.31</ci_lower_limit>
            <ci_upper_limit>3.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.35</ci_lower_limit>
            <ci_upper_limit>2.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.46</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.94</ci_lower_limit>
            <ci_upper_limit>1.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.48</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.19</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.51</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.26</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.51</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.02</ci_lower_limit>
            <ci_upper_limit>2.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.49</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.39</ci_lower_limit>
            <ci_upper_limit>2.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.50</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>4.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.11</ci_lower_limit>
            <ci_upper_limit>3.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.76</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.38</ci_lower_limit>
            <ci_upper_limit>3.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.85</ci_lower_limit>
            <ci_upper_limit>4.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.50</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.36</ci_lower_limit>
            <ci_upper_limit>2.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
        <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>bpm</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-0.54" upper_limit="0.91"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-0.24" upper_limit="1.25"/>
                    <measurement group_id="O3" value="0.4" lower_limit="-0.34" upper_limit="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0.64" upper_limit="0.87"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-0.78" upper_limit="0.78"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-0.61" upper_limit="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-1.29" upper_limit="0.54"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-1.28" upper_limit="0.60"/>
                    <measurement group_id="O3" value="0.1" lower_limit="-0.85" upper_limit="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-1.35" upper_limit="0.47"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-0.64" upper_limit="1.24"/>
                    <measurement group_id="O3" value="0.1" lower_limit="-0.83" upper_limit="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="3.52" upper_limit="6.00"/>
                    <measurement group_id="O2" value="4.7" lower_limit="3.43" upper_limit="5.97"/>
                    <measurement group_id="O3" value="5.4" lower_limit="4.17" upper_limit="6.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" lower_limit="6.02" upper_limit="8.80"/>
                    <measurement group_id="O2" value="7.9" lower_limit="6.45" upper_limit="9.31"/>
                    <measurement group_id="O3" value="8.1" lower_limit="6.69" upper_limit="9.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.24" upper_limit="3.24"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-0.49" upper_limit="1.55"/>
                    <measurement group_id="O3" value="2.8" lower_limit="1.75" upper_limit="3.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.75 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-1.81" upper_limit="0.64"/>
                    <measurement group_id="O2" value="0.9" lower_limit="-0.34" upper_limit="2.16"/>
                    <measurement group_id="O3" value="1.6" lower_limit="0.35" upper_limit="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.36" upper_limit="1.09"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-0.91" upper_limit="1.59"/>
                    <measurement group_id="O3" value="1.6" lower_limit="0.32" upper_limit="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.25 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-0.94" upper_limit="1.62"/>
                    <measurement group_id="O2" value="1.0" lower_limit="-0.32" upper_limit="2.30"/>
                    <measurement group_id="O3" value="1.8" lower_limit="0.46" upper_limit="3.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="-0.74" upper_limit="1.60"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.16" upper_limit="2.55"/>
                    <measurement group_id="O3" value="2.0" lower_limit="0.85" upper_limit="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="-0.84" upper_limit="1.57"/>
                    <measurement group_id="O2" value="1.1" lower_limit="-0.14" upper_limit="2.32"/>
                    <measurement group_id="O3" value="2.0" lower_limit="0.82" upper_limit="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="-0.70" upper_limit="1.88"/>
                    <measurement group_id="O2" value="1.2" lower_limit="-0.07" upper_limit="2.56"/>
                    <measurement group_id="O3" value="2.5" lower_limit="1.22" upper_limit="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.27" upper_limit="2.67"/>
                    <measurement group_id="O2" value="1.8" lower_limit="0.59" upper_limit="3.05"/>
                    <measurement group_id="O3" value="2.9" lower_limit="1.63" upper_limit="4.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="3.79" upper_limit="6.70"/>
                    <measurement group_id="O2" value="5.6" lower_limit="4.08" upper_limit="7.07"/>
                    <measurement group_id="O3" value="6.3" lower_limit="4.79" upper_limit="7.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="7.31" upper_limit="10.01"/>
                    <measurement group_id="O2" value="9.2" lower_limit="7.83" upper_limit="10.59"/>
                    <measurement group_id="O3" value="9.8" lower_limit="8.41" upper_limit="11.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.93" upper_limit="3.60"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.21" upper_limit="2.94"/>
                    <measurement group_id="O3" value="3.3" lower_limit="1.90" upper_limit="4.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.20</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.62</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.08</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.76</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.73</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.75</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.80</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.05</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.42</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.18</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.66</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.83</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.91</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.90</ci_lower_limit>
            <ci_upper_limit>-0.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.41</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.08</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.21</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.98</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.25</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.01</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.36</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.75</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.01</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.06</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.24</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.08</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.03</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.87</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.89</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.62</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.77</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.76</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.50</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.19</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.22</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.63</ci_lower_limit>
            <ci_upper_limit>-0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.42</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.96</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.58</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.99</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.34</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.65</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.10</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.11</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.73</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.25</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.77</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.50</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.57</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.</description>
        <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-2.43" upper_limit="-0.43"/>
                    <measurement group_id="O2" value="-0.9" lower_limit="-1.88" upper_limit="0.18"/>
                    <measurement group_id="O3" value="-0.2" lower_limit="-1.28" upper_limit="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-1.45" upper_limit="0.84"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-1.55" upper_limit="0.80"/>
                    <measurement group_id="O3" value="-0.3" lower_limit="-1.46" upper_limit="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-2.79" upper_limit="-0.40"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-3.22" upper_limit="-0.74"/>
                    <measurement group_id="O3" value="-2.0" lower_limit="-3.26" upper_limit="-0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-2.76" upper_limit="-0.33"/>
                    <measurement group_id="O2" value="-1.9" lower_limit="-3.12" upper_limit="-0.62"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-2.44" upper_limit="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" lower_limit="-7.80" upper_limit="-4.72"/>
                    <measurement group_id="O2" value="-6.5" lower_limit="-8.08" upper_limit="-4.91"/>
                    <measurement group_id="O3" value="-7.4" lower_limit="-9.02" upper_limit="-5.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" lower_limit="-5.75" upper_limit="-2.09"/>
                    <measurement group_id="O2" value="-5.5" lower_limit="-7.39" upper_limit="-3.60"/>
                    <measurement group_id="O3" value="-4.2" lower_limit="-6.10" upper_limit="-2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-2.76" upper_limit="-0.01"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-1.73" upper_limit="1.07"/>
                    <measurement group_id="O3" value="-0.3" lower_limit="-1.70" upper_limit="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.75 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="1.84" upper_limit="5.69"/>
                    <measurement group_id="O2" value="4.5" lower_limit="2.56" upper_limit="6.49"/>
                    <measurement group_id="O3" value="3.1" lower_limit="1.17" upper_limit="5.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2.11" upper_limit="6.08"/>
                    <measurement group_id="O2" value="5.0" lower_limit="2.97" upper_limit="7.02"/>
                    <measurement group_id="O3" value="3.8" lower_limit="1.75" upper_limit="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.25 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="1.24" upper_limit="5.21"/>
                    <measurement group_id="O2" value="4.5" lower_limit="2.46" upper_limit="6.52"/>
                    <measurement group_id="O3" value="3.0" lower_limit="0.94" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="0.67" upper_limit="5.11"/>
                    <measurement group_id="O2" value="2.7" lower_limit="0.44" upper_limit="4.98"/>
                    <measurement group_id="O3" value="2.9" lower_limit="0.64" upper_limit="5.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="0.99" upper_limit="5.12"/>
                    <measurement group_id="O2" value="2.1" lower_limit="-0.04" upper_limit="4.19"/>
                    <measurement group_id="O3" value="2.6" lower_limit="0.49" upper_limit="4.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-1.85" upper_limit="2.23"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-0.25" upper_limit="3.92"/>
                    <measurement group_id="O3" value="0.7" lower_limit="-1.36" upper_limit="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-2.95" upper_limit="1.05"/>
                    <measurement group_id="O2" value="0.9" lower_limit="-1.10" upper_limit="2.99"/>
                    <measurement group_id="O3" value="-0.2" lower_limit="-2.29" upper_limit="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" lower_limit="-6.90" upper_limit="-3.22"/>
                    <measurement group_id="O2" value="-3.7" lower_limit="-5.55" upper_limit="-1.79"/>
                    <measurement group_id="O3" value="-4.3" lower_limit="-6.23" upper_limit="-2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" lower_limit="-4.65" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="-0.9" lower_limit="-2.86" upper_limit="0.99"/>
                    <measurement group_id="O3" value="-4.2" lower_limit="-6.14" upper_limit="-2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="-0.99" upper_limit="2.84"/>
                    <measurement group_id="O2" value="3.1" lower_limit="1.18" upper_limit="5.08"/>
                    <measurement group_id="O3" value="1.1" lower_limit="-0.82" upper_limit="3.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.83</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.56</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.96</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.62</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.22</ci_lower_limit>
            <ci_upper_limit>2.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.04</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.31</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.00</ci_lower_limit>
            <ci_upper_limit>3.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.56</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.30</ci_lower_limit>
            <ci_upper_limit>2.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.00</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.08</ci_lower_limit>
            <ci_upper_limit>3.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.69</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.48</ci_lower_limit>
            <ci_upper_limit>3.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.69</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.55</ci_lower_limit>
            <ci_upper_limit>3.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.90</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.17</ci_lower_limit>
            <ci_upper_limit>3.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.77</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.47</ci_lower_limit>
            <ci_upper_limit>3.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.74</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.42</ci_lower_limit>
            <ci_upper_limit>2.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.71</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.54</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.57</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.31</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.60</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>4.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.63</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.90</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.00</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.39</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.26</ci_lower_limit>
            <ci_upper_limit>3.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.59</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-3.92</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.16</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.96</ci_lower_limit>
            <ci_upper_limit>1.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.65</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>4.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.71</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.61</ci_lower_limit>
            <ci_upper_limit>4.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.71</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.32</ci_lower_limit>
            <ci_upper_limit>4.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.92</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.38</ci_lower_limit>
            <ci_upper_limit>2.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.78</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-3.48</ci_lower_limit>
            <ci_upper_limit>2.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.76</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.81</ci_lower_limit>
            <ci_upper_limit>4.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.72</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.67</ci_lower_limit>
            <ci_upper_limit>4.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.58</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.95</ci_lower_limit>
            <ci_upper_limit>3.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>3.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.62</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>5.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>2.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.72</ci_lower_limit>
            <ci_upper_limit>4.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
        <description>Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
        <time_frame>Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings</title>
          <description>Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-0.25" upper_limit="0.01"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-0.22" upper_limit="0.05"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-0.15" upper_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0.06" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.05" upper_limit="0.22"/>
                    <measurement group_id="O3" value="-0.1" lower_limit="-0.22" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.13" upper_limit="0.17"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.17" upper_limit="0.14"/>
                    <measurement group_id="O3" value="0.1" lower_limit="-0.05" upper_limit="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.17" upper_limit="0.14"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.02" upper_limit="0.31"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-0.14" upper_limit="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-0.83" upper_limit="-0.16"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-0.66" upper_limit="0.03"/>
                    <measurement group_id="O3" value="-0.4" lower_limit="-0.74" upper_limit="-0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-0.58" upper_limit="0.26"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-0.25" upper_limit="0.63"/>
                    <measurement group_id="O3" value="-0.1" lower_limit="-0.55" upper_limit="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-0.22" upper_limit="0.15"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.04" upper_limit="0.33"/>
                    <measurement group_id="O3" value="-0.2" lower_limit="-0.37" upper_limit="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.75 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.03" upper_limit="0.79"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.18" upper_limit="0.95"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-0.18" upper_limit="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.03" upper_limit="0.79"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.08" upper_limit="0.86"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-0.35" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.25 hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.15" upper_limit="0.92"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.12" upper_limit="0.91"/>
                    <measurement group_id="O3" value="0.00" lower_limit="-0.37" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.10" upper_limit="0.87"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.09" upper_limit="0.86"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-0.19" upper_limit="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.18" upper_limit="0.94"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.21" upper_limit="0.98"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-0.19" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.12" upper_limit="0.89"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-0.04" upper_limit="0.75"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-0.35" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.00" upper_limit="0.79"/>
                    <measurement group_id="O2" value="0.7" lower_limit="0.25" upper_limit="1.06"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-0.39" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0.38" upper_limit="0.62"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-0.14" upper_limit="0.88"/>
                    <measurement group_id="O3" value="-0.3" lower_limit="-0.77" upper_limit="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.06" upper_limit="1.15"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.06" upper_limit="1.17"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-0.23" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.15" upper_limit="0.98"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.07" upper_limit="0.91"/>
                    <measurement group_id="O3" value="0.00" lower_limit="-0.38" upper_limit="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.37</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>032</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.47</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.40</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.37</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.27</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.44</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.48</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Categorical Outliers for QTcF</title>
        <description>The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values &gt; 450 and ≤ 480 ms, &gt; 480 and ≤ 500 ms, or &gt; 500 ms.</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Categorical Outliers for QTcF</title>
          <description>The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values &gt; 450 and ≤ 480 ms, &gt; 480 and ≤ 500 ms, or &gt; 500 ms.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QTcF&gt;450 and &lt;=480 ms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF&gt;480 and &lt;=500 ms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF&gt;500 ms</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Categorical Outliers for HR</title>
        <description>Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline &gt; 25% to a HR &lt; 50 bpm; and increase in HR from pre-dose baseline &gt; 25% to a HR &gt; 100 bpm.</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Categorical Outliers for HR</title>
          <description>Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline &gt; 25% to a HR &lt; 50 bpm; and increase in HR from pre-dose baseline &gt; 25% to a HR &gt; 100 bpm.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="52"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HR &lt; 50 (bpm) with a decrease in ΔHR &gt; 25%</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HR &gt; 100 (bpm) with an increase in ΔHR &gt; 25%</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Categorical Outliers for PR</title>
        <description>PR outliers criteria is as an increase of PR from baseline &gt;25% resulting in PR &gt;200 ms.</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of Balovaptan</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Categorical Outliers for PR</title>
          <description>PR outliers criteria is as an increase of PR from baseline &gt;25% resulting in PR &gt;200 ms.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Categorical Outliers for QRS</title>
        <description>QRS outlier criteria is an increase of QRS from baseline &gt;25% resulting in QRS &gt;120 ms.</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>All participants received Treatment A and Treatment B and either Treatment C or Treatment D.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Categorical Outliers for QRS</title>
          <description>QRS outlier criteria is an increase of QRS from baseline &gt;25% resulting in QRS &gt;120 ms.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Changes of T-Wave Morphology</title>
        <description>Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Changes of T-Wave Morphology</title>
          <description>Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Flat T-wave</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Notched T-wave (+)</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biphasic T-wave</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal T-wave (-)</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Notched T-wave (-)</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Changes of U-Wave Presence</title>
        <description>Number (percentage) of participants with treatment emergent changes of U-wave presence.</description>
        <time_frame>Up to approximately 20 weeks</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Changes of U-Wave Presence</title>
          <description>Number (percentage) of participants with treatment emergent changes of U-wave presence.</description>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</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="55"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of Balovaptan</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Balovaptan</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="1.00" upper_limit="8.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.50" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1.00" upper_limit="8.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.50" upper_limit="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of M2 Metabolite</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of M2 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.92" lower_limit="12.00" upper_limit="23.95"/>
                    <measurement group_id="O2" value="23.92" lower_limit="12.00" upper_limit="23.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="0.50" upper_limit="23.83"/>
                    <measurement group_id="O2" value="6.00" lower_limit="0.50" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax M3 Metabolite</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose Level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax M3 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.92" lower_limit="6.00" upper_limit="23.95"/>
                    <measurement group_id="O2" value="8.00" lower_limit="1.00" upper_limit="23.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="0.50" upper_limit="8.00"/>
                    <measurement group_id="O2" value="4.01" lower_limit="0.50" upper_limit="8.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of Balovaptan</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Balovaptan</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="11.84"/>
                    <measurement group_id="O2" value="362.7" spread="122.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.8" spread="28.98"/>
                    <measurement group_id="O2" value="613.4" spread="191.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of M2 Metabolite</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of M2 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.69" spread="1.828"/>
                    <measurement group_id="O2" value="42.75" spread="11.965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.77" spread="6.057"/>
                    <measurement group_id="O2" value="152.83" spread="40.855"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of M3 Metabolite</title>
        <time_frame>Day 1 and Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of Balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of M3 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.83" spread="1.697"/>
                    <measurement group_id="O2" value="71.12" spread="17.615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1005.2" spread="233.87"/>
                    <measurement group_id="O2" value="5456.9" spread="1253.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-24 of Balovaptan</title>
        <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-24 of Balovaptan</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="55"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="440.7" spread="121.92"/>
                    <measurement group_id="O2" value="3524.8" spread="956.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1127.6" spread="372.72"/>
                    <measurement group_id="O2" value="6377.9" spread="2149.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-24 of M2 Metabolite</title>
        <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-24 of M2 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="30.55"/>
                    <measurement group_id="O2" value="766.6" spread="222.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.5" spread="123.23"/>
                    <measurement group_id="O2" value="3127.0" spread="807.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-24 of M3 Metabolite</title>
        <time_frame>Day 1 and Day 14 (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-24 of M3 Metabolite</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </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="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.2" spread="37.49"/>
                    <measurement group_id="O2" value="1404.2" spread="344.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1005.2" spread="233.87"/>
                    <measurement group_id="O2" value="5456.9" spread="1253.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of Moxifloxacin</title>
        <time_frame>Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment C</title>
            <description>Participants in Treatment C received 400 mg of Moxifloxacin on Day 2.</description>
          </group>
          <group group_id="O2">
            <title>Treatment D</title>
            <description>Participants in Treatment D received 400 mg of Moxifloxacin on Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Moxifloxacin</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="0.50" upper_limit="4.02"/>
                    <measurement group_id="O2" value="1.78" lower_limit="0.50" upper_limit="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of Moxifloxacin</title>
        <time_frame>Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment C</title>
            <description>Participants in Treatment C received 400 mg of Moxifloxacin on Day 2.</description>
          </group>
          <group group_id="O2">
            <title>Treatment D</title>
            <description>Participants in Treatment D received 400 mg of Moxifloxacin on Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Moxifloxacin</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2056.9" spread="437.64"/>
                    <measurement group_id="O2" value="2058.8" spread="525.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-24 of Moxifloxacin</title>
        <time_frame>Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)</time_frame>
        <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment C</title>
            <description>Participants in Treatment C received 400 mg of moxifloxacin on Day 2.</description>
          </group>
          <group group_id="O2">
            <title>Treatment D</title>
            <description>Participants in Treatment D received 400 mg of moxifloxacin on Day 15.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-24 of Moxifloxacin</title>
          <population>PK population included all participants who received at least 1 dose of investigational product and had at least 1 evaluable pharmacokinetic (PK) plasma concentration for any of balovaptan, M2 and M3 (and moxifloxacin, when applicable).</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22503.9" spread="4103.73"/>
                    <measurement group_id="O2" value="24103.1" spread="5169.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis</title>
        <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose A of Balovaptan</title>
            <description>Participants received dose A of Balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose B of Balovaptan</title>
            <description>Participants received dose B of balovaptan</description>
          </group>
        </group_list>
        <measure>
          <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis</title>
          <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
          <units>ms</units>
          <param>Geometric Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" lower_limit="-0.20" upper_limit="2.31"/>
                    <measurement group_id="O2" value="0.70" lower_limit="-1.49" upper_limit="2.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis</title>
        <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis</title>
          <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
          <units>ms</units>
          <param>Geometric Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" lower_limit="-0.30" upper_limit="2.31"/>
                    <measurement group_id="O2" value="0.27" lower_limit="-2.47" upper_limit="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis</title>
        <time_frame>Baseline, Day 14. (Each treatment period is 15 days.)</time_frame>
        <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Level A of Balovaptan</title>
            <description>Participants received dose level A of balovaptan.</description>
          </group>
          <group group_id="O2">
            <title>Dose Level B of Balovaptan</title>
            <description>Participants received dose level B of balovaptan.</description>
          </group>
        </group_list>
        <measure>
          <title>Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis</title>
          <population>PK/QTc population included all participants who were in both the QT/QTc and PK populations with at least 1 pair of post-dose PK and QTcF data from the same time point.</population>
          <units>ms</units>
          <param>Geometric Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" lower_limit="-0.17" upper_limit="2.27"/>
                    <measurement group_id="O2" value="0.23" lower_limit="-2.38" upper_limit="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records</title>
        <time_frame>Baseline, Day 15. (Each treatment period is 15 days.)</time_frame>
        <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
        <group_list>
          <group group_id="O1">
            <title>Moxifloxacin</title>
            <description>Participants received 400 mg of moxifloxacin</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records</title>
          <population>QT/QTc population included all participants in the Safety population with ECG measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTcF value.</population>
          <units>ms</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-4.01" upper_limit="0.02"/>
                    <measurement group_id="O2" value="-3.2" lower_limit="-5.21" upper_limit="-1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="1.14" upper_limit="5.69"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-4.29" upper_limit="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="4.28" upper_limit="8.16"/>
                    <measurement group_id="O2" value="-2.3" lower_limit="-4.27" upper_limit="-0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="5.54" upper_limit="9.44"/>
                    <measurement group_id="O2" value="-1.1" lower_limit="-3.06" upper_limit="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" lower_limit="-3.53" upper_limit="0.86"/>
                    <measurement group_id="O2" value="-9.9" lower_limit="-12.05" upper_limit="-7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-2.16" upper_limit="2.27"/>
                    <measurement group_id="O2" value="-6.8" lower_limit="-9.05" upper_limit="-4.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours Post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="2.14" upper_limit="5.75"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-3.97" upper_limit="-0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.71</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.64</ci_lower_limit>
            <ci_upper_limit>4.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>5.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.93</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.22</ci_lower_limit>
            <ci_upper_limit>8.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>8.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.81</ci_lower_limit>
            <ci_upper_limit>11.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>8.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.65</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.86</ci_lower_limit>
            <ci_upper_limit>11.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>8.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.43</ci_lower_limit>
            <ci_upper_limit>11.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>6.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.88</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.76</ci_lower_limit>
            <ci_upper_limit>10.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose</non_inferiority_desc>
            <param_type>LS Mean</param_type>
            <param_value>6.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.58</ci_lower_limit>
            <ci_upper_limit>8.62</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment Emergent Adverse Events</title>
        <time_frame>Up to approximately 20 weeks.</time_frame>
        <population>Groups C&amp;D together are positive control to balovaptan. Moxifloxacin is given in a nested cross-over way using a joint placebo/positive control period, half subjects dosed with moxifloxacin on Day 2 and other half dosed on Day 15.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Sequence A and B and Either C or D</title>
            <description>All participants received Treatment A and Treatment B and either Treatment C or Treatment D.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Emergent Adverse Events</title>
          <population>Groups C&amp;D together are positive control to balovaptan. Moxifloxacin is given in a nested cross-over way using a joint placebo/positive control period, half subjects dosed with moxifloxacin on Day 2 and other half dosed on Day 15.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first study drug to the data cutoff date: 13 July 2019 (up to 20 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment A Dose Level A</title>
          <description>Participants in treatment A received balovaptan at dose level A.</description>
        </group>
        <group group_id="E2">
          <title>Treatment B Dose Level B</title>
          <description>Participants in treatment B received balovaptan at dose level B.</description>
        </group>
        <group group_id="E3">
          <title>Treatment C Placebo + Moxifloxacin 400 mg Day 2</title>
          <description>Participants in treatment C received placebo plus 400 mg of moxifloxacin on Day 2.</description>
        </group>
        <group group_id="E4">
          <title>Treatment D Placebo + Moxifloxacin 400 mg Day 15</title>
          <description>Participants in treatment D received placebo plus 400 mg moxifloxacin on Day 15.</description>
        </group>
        <group group_id="E5">
          <title>All Participants</title>
          <description>All participants received Treatment A and Treatment B and either Treatment C or Treatment D.</description>
        </group>
      </group_list>
      <serious_events>
        <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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="15" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT03808298
org study id: WP40734
nct id: NCT03808298
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled,
      positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of
      balovaptan on the QTc interval in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)
description: Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.
measure: Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)
description: Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.
measure: Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
description: Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.
measure: Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
description: Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.
measure: Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
description: Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.
measure: Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings
time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
description: Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.
measure: Number of Categorical Outliers for QTcF
time frame: Up to approximately 20 weeks
description: The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values > 450 and ≤ 480 ms, > 480 and ≤ 500 ms, or > 500 ms.
measure: Number of Categorical Outliers for HR
time frame: Up to approximately 20 weeks
description: Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline > 25% to a HR < 50 bpm; and increase in HR from pre-dose baseline > 25% to a HR > 100 bpm.
measure: Number of Categorical Outliers for PR
time frame: Up to approximately 20 weeks
description: PR outliers criteria is as an increase of PR from baseline >25% resulting in PR >200 ms.
measure: Number of Categorical Outliers for QRS
time frame: Up to approximately 20 weeks
description: QRS outlier criteria is an increase of QRS from baseline >25% resulting in QRS >120 ms.
measure: Number of Treatment Emergent Changes of T-Wave Morphology
time frame: Up to approximately 20 weeks
description: Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).
measure: Number of Treatment Emergent Changes of U-Wave Presence
time frame: Up to approximately 20 weeks
description: Number (percentage) of participants with treatment emergent changes of U-wave presence.
measure: Tmax of Balovaptan
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: Tmax of M2 Metabolite
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: Tmax M3 Metabolite
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: Cmax of Balovaptan
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: Cmax of M2 Metabolite
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: Cmax of M3 Metabolite
time frame: Day 1 and Day 14. (Each treatment period is 15 days.)
measure: AUC0-24 of Balovaptan
time frame: Day 1 and Day 14 (Each treatment period is 15 days.)
measure: AUC0-24 of M2 Metabolite
time frame: Day 1 and Day 14 (Each treatment period is 15 days.)
measure: AUC0-24 of M3 Metabolite
time frame: Day 1 and Day 14 (Each treatment period is 15 days.)
measure: Tmax of Moxifloxacin
time frame: Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.)
measure: Cmax of Moxifloxacin
time frame: Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)
measure: AUC0-24 of Moxifloxacin
time frame: Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)
measure: Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis
time frame: Baseline, Day 14. (Each treatment period is 15 days.)
measure: Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis
time frame: Baseline, Day 14. (Each treatment period is 15 days.)
measure: Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis
time frame: Baseline, Day 14. (Each treatment period is 15 days.)
measure: Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records
time frame: Baseline, Day 15. (Each treatment period is 15 days.)
measure: Percentage of Participants With Treatment Emergent Adverse Events
time frame: Up to approximately 20 weeks.
arm group label: Treatment Sequence 1: A, B, C
arm group type: Experimental
arm group label: Treatment Sequence 2: A, C, B
arm group type: Experimental
arm group label: Treatment Sequence 3: B, A, C
arm group type: Experimental
arm group label: Treatment Sequence 4: B, C, A
arm group type: Experimental
arm group label: Treatment Sequence 5: C, A, B
arm group type: Experimental
arm group label: Treatment Sequence 6: C, B, A
arm group type: Experimental
arm group label: Treatment Sequence 7: A, B, D
arm group type: Experimental
arm group label: Treatment Sequence 8: A, D, B
arm group type: Experimental
arm group label: Treatment Sequence 9: B, A, D
arm group type: Experimental
arm group label: Treatment Sequence 10: B, D, A
arm group type: Experimental
arm group label: Treatment Sequence 11: D, A, B
arm group type: Experimental
arm group label: Treatment Sequence 12: D, B, A
arm group type: Experimental
intervention type: Drug
intervention name: Balovaptan therapeutic dose Treatment A
description: Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Balovaptan supra-therapeutic dose Treatment B
description: Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Active control [moxifloxacin] on Day 2 Treatment C
description: Day 2: A single oral dose of 400 mg moxifloxacin capsule.
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
intervention type: Drug
intervention name: Active control [Moxifloxacin] on Day 15 Treatment D
description: Day 15: A single oral dose of 400 mg moxifloxacin capsule.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Placebo for Balovaptan Treatment C
description: Days 1-14: Matching placebo for balovaptan for 14 days.
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
intervention type: Drug
intervention name: Placebo for Balovaptan Treatment D
description: Days 1-14: Matching placebo for balovaptan for 14 days.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Placebo for Moxifloxacin Treatment A
description: Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Placebo for Moxifloxacin Treatment B
description: Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Moxifloxacin Treatment C
description: Day 2: A single oral dose of 400 mg moxifloxacin capsule.
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
intervention type: Drug
intervention name: Placebo for Moxifloxacin Treatment C
description: Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
arm group label: Treatment Sequence 1: A, B, C
arm group label: Treatment Sequence 2: A, C, B
arm group label: Treatment Sequence 3: B, A, C
arm group label: Treatment Sequence 4: B, C, A
arm group label: Treatment Sequence 5: C, A, B
arm group label: Treatment Sequence 6: C, B, A
intervention type: Drug
intervention name: Placebo for Moxifloxacin Treatment D
description: Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
intervention type: Drug
intervention name: Moxifloxacin Treatment D
description: Day 15: A single oral dose of 400 mg moxifloxacin capsule.
arm group label: Treatment Sequence 10: B, D, A
arm group label: Treatment Sequence 11: D, A, B
arm group label: Treatment Sequence 12: D, B, A
arm group label: Treatment Sequence 7: A, B, D
arm group label: Treatment Sequence 8: A, D, B
arm group label: Treatment Sequence 9: B, A, D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Moxifloxacin
mesh term: Balovaptan
mesh term: Norgestimate, ethinyl estradiol drug combination
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 