<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/NCT03016325</url>
  </required_header>
  <id_info>
    <org_study_id>CV013-011</org_study_id>
    <secondary_id>2016-001685-29</secondary_id>
    <nct_id>NCT03016325</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure</brief_title>
  <acronym>STANDUP AHF</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO&#xD;
      Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">November 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 23, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion</measure>
    <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
    <description>Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) &lt; 90 mm Hg (confirmed by a repeated value &lt; 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32</measure>
    <time_frame>0, 24, 48, 72, 120 hour or discharge; Day 32</time_frame>
    <description>Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72</measure>
    <time_frame>Hours 6, 12, 24, 48, and 72</time_frame>
    <description>Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.&#xD;
Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).&#xD;
The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.&#xD;
A score of 0 represents &quot;I am not breathless at all&quot; and 10 represents &quot;I am the most breathless I can possibly imagine&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion</measure>
    <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
    <description>The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SBP &lt; 90 mm Hg (Confirmed by a Repeated Value)</measure>
    <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
    <description>The percentage of participants experiencing SBP &lt; 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32</measure>
    <time_frame>32 days</time_frame>
    <description>Number of participants who experienced an in-study SAE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Due to Hypotension</measure>
    <time_frame>up to 120 hours (for AEs); up to 32 days (for SAEs)</time_frame>
    <description>Number of participants who discontinued study treatment due to hypotension.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
Hypotension defined as systolic blood pressure (SBP) &lt; 90 mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure</measure>
    <time_frame>up to 120 hours (for AEs); up to 32 days (for SAEs)</time_frame>
    <description>Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
If the participant experienced systolic blood pressure (SBP) &lt; 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained &lt; 95 mm Hg, the dose reduction occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours</measure>
    <time_frame>up to 120 hours</time_frame>
    <description>Number of participants who experienced an in-study AE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182</measure>
    <time_frame>through 182 days</time_frame>
    <description>Number of participants who died (all- cause and CV related) through Day 182.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
CV=Cardiovascular</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Troponin T From Baseline to Hour 24, 48, and 72</measure>
    <time_frame>from baseline to Hour 24, 48, and 72</time_frame>
    <description>Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology</measure>
    <time_frame>to 120 hours</time_frame>
    <description>Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry</measure>
    <time_frame>to 120 hours</time_frame>
    <description>Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis</measure>
    <time_frame>to 120 hours</time_frame>
    <description>Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vital Signs From Baseline to 120 Hours - Blood Pressure</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for vital signs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vital Signs From Baseline to 120 Hours - Heart Rate</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for vital signs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for vital signs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vital Signs From Baseline to 120 Hours - Temperature</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for vital signs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for ECGs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for ECGs was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Measurements From Baseline to 120 Hours</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for physical measurements was reported for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion</measure>
    <time_frame>to 120 hours</time_frame>
    <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">329</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Part 1 Cohort 1 HNO Donor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part 1 Cohort 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Cohort 2 HNO Donor- low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Cohort 2 HNO Donor- high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part 2 Cohort 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HNO Donor</intervention_name>
    <description>Infusion</description>
    <arm_group_label>Part 1 Cohort 1 HNO Donor</arm_group_label>
    <arm_group_label>Part 2 Cohort 2 HNO Donor- high dose</arm_group_label>
    <arm_group_label>Part 2 Cohort 2 HNO Donor- low dose</arm_group_label>
    <other_name>BMS-986231</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Infusion</description>
    <arm_group_label>Placebo Part 1 Cohort 1</arm_group_label>
    <arm_group_label>Placebo Part 2 Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Actively being hospitalized for acute decompensated heart failure&#xD;
&#xD;
          -  At least 1 administration of IV diuretic for the current episode&#xD;
&#xD;
          -  Be randomized within 18 hours of first dose of IV diuretic for current episode for&#xD;
             Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II&#xD;
&#xD;
          -  Have shortness of breath at rest or with minimal exertion after administration of 1&#xD;
             dose of IV diuretic&#xD;
&#xD;
          -  Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systolic blood pressure &lt;105mm Hg or &gt;160mm Hg or heart rate &lt;50 or &gt;130 bpm&#xD;
&#xD;
          -  Have an active infection requiring IV anti-microbial treatment&#xD;
&#xD;
          -  Be hospitalized with acute coronary syndrome, coronary revascularization or acute&#xD;
             myocardial infarction during the previous 90 days prior to screening&#xD;
&#xD;
          -  Have a history of a cerebral vascular accident (CVA or stroke) or of a transient&#xD;
             ischemic attack (TIA) during the previous 90 days prior to screening&#xD;
&#xD;
          -  Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease&#xD;
             (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona Sarver Heart Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DMC Detroit Receiving Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harper University Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexner Medical Center at The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina - PPDS</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ben Taub General Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Medical Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1428ART</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Rosario</city>
        <state>Santa FE</state>
        <zip>Santa Fe, 2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
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    <description>FDA Safety Alerts and Recalls</description>
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  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>June 22, 2020</results_first_submitted>
  <results_first_submitted_qc>August 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 19, 2020</results_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <provided_document_section>
    <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>June 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03016325/SAP_001.pdf</document_url>
    </provided_document>
    <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 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03016325/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Main study cohorts: 100 participants in Part I and 222 in Part II were assigned to treatment (322 randomized in total), of which 97 and 214, respectively, were treated (311 total treated). Reasons not treated (Part I): 3 other reasons. Reasons not treated (Part II): 2 no longer met study criteria; 1 adverse event (AE); 5 other reasons.&#xD;
Japanese-specific cohort: 18 participants were randomized and treated in Part II (Japan cohort)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo - Part I</title>
          <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="P2">
          <title>BMS-986231 - Part I</title>
          <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="P3">
          <title>Placebo - Part II</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="P4">
          <title>BMS-986231 6 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="P5">
          <title>BMS-986231 12 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="P6">
          <title>Placebo - Part II (Japan Cohort)</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="P7">
          <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="P8">
          <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="72"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="70"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="70"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant refuses assessments</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>32-Day Follow-Up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="72"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="62"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="64"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant refused to visit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Family doctor OK'd participant, per call</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>withdrew from Day 5, D32 form not done</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>182-Day Follow-Up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="72"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="60"/>
                <participants group_id="P4" count="58"/>
                <participants group_id="P5" count="60"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Alive, per national insurance system</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Alive, per Family doctor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Alive, per civil unit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Vital status collected via EMR</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>withdrew from D5, D32/182 forms not done</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No cont D182 FU, Sponsor admin reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo - Part I</title>
          <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="B2">
          <title>BMS-986231 - Part I</title>
          <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="B3">
          <title>Placebo - Part II</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="B4">
          <title>BMS-986231 6 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="B5">
          <title>BMS-986231 12 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="B6">
          <title>Placebo - Part II (Japan Cohort)</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="B7">
          <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="B8">
          <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="48"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="71"/>
            <count group_id="B4" value="71"/>
            <count group_id="B5" value="72"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="329"/>
          </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="66.0" spread="12.23"/>
                    <measurement group_id="B2" value="64.6" spread="12.23"/>
                    <measurement group_id="B3" value="67.3" spread="11.52"/>
                    <measurement group_id="B4" value="69.2" spread="11.41"/>
                    <measurement group_id="B5" value="70.0" spread="11.52"/>
                    <measurement group_id="B6" value="65.3" spread="17.88"/>
                    <measurement group_id="B7" value="69.5" spread="13.31"/>
                    <measurement group_id="B8" value="76.7" spread="10.48"/>
                    <measurement group_id="B9" value="67.9" spread="11.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Age categorical</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65 -to &lt;=75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="86"/>
                  </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="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="57"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="41"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="66"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion</title>
        <description>Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) &lt; 90 mm Hg (confirmed by a repeated value &lt; 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion</description>
        <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion</title>
          <description>Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) &lt; 90 mm Hg (confirmed by a repeated value &lt; 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>clinically relevant hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="2.32" upper_limit="19.98"/>
                    <measurement group_id="O2" value="20.4" lower_limit="10.24" upper_limit="34.34"/>
                    <measurement group_id="O3" value="18.3" lower_limit="10.13" upper_limit="29.27"/>
                    <measurement group_id="O4" value="21.1" lower_limit="12.33" upper_limit="32.44"/>
                    <measurement group_id="O5" value="34.7" lower_limit="23.88" upper_limit="46.86"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="33.3" lower_limit="4.33" upper_limit="77.72"/>
                    <measurement group_id="O8" value="50.0" lower_limit="11.81" upper_limit="88.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>symptoms of hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.05" upper_limit="11.07"/>
                    <measurement group_id="O2" value="6.1" lower_limit="1.28" upper_limit="16.87"/>
                    <measurement group_id="O3" value="1.4" lower_limit="0.04" upper_limit="7.60"/>
                    <measurement group_id="O4" value="2.8" lower_limit="0.34" upper_limit="9.81"/>
                    <measurement group_id="O5" value="8.3" lower_limit="3.12" upper_limit="17.26"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O8" value="0" lower_limit="0.00" upper_limit="45.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>confirmed SBP &lt; 90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="1.31" upper_limit="17.20"/>
                    <measurement group_id="O2" value="20.4" lower_limit="10.24" upper_limit="34.34"/>
                    <measurement group_id="O3" value="18.3" lower_limit="10.13" upper_limit="29.27"/>
                    <measurement group_id="O4" value="21.1" lower_limit="12.33" upper_limit="32.44"/>
                    <measurement group_id="O5" value="29.2" lower_limit="19.05" upper_limit="41.07"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="33.3" lower_limit="4.33" upper_limit="77.72"/>
                    <measurement group_id="O8" value="50.0" lower_limit="11.81" upper_limit="88.19"/>
                  </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>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, clinically relevant hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>2.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>14.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, clinically relevant hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>2.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>75.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>3.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>14.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), clinically relevant hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), clinically relevant hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>54.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), clinically relevant hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>3.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), clinically relevant hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.01</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>5.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>149.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>3.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (low dose), clinically relevant hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (low dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (high dose), clinically relevant hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (high dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32</title>
        <description>Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)</description>
        <time_frame>0, 24, 48, 72, 120 hour or discharge; Day 32</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32</title>
          <description>Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)</description>
          <population>All treated participants</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-270.88" spread="400.320"/>
                    <measurement group_id="O2" value="-364.46" spread="456.158"/>
                    <measurement group_id="O3" value="-147.96" spread="452.239"/>
                    <measurement group_id="O4" value="-340.74" spread="430.639"/>
                    <measurement group_id="O5" value="-416.91" spread="503.825"/>
                    <measurement group_id="O6" value="-129.70" spread="255.716"/>
                    <measurement group_id="O7" value="-165.93" spread="185.910"/>
                    <measurement group_id="O8" value="-397.60" spread="330.721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-405.06" spread="591.711"/>
                    <measurement group_id="O2" value="-510.51" spread="592.734"/>
                    <measurement group_id="O3" value="-210.87" spread="580.487"/>
                    <measurement group_id="O4" value="-300.87" spread="725.268"/>
                    <measurement group_id="O5" value="-472.32" spread="610.590"/>
                    <measurement group_id="O6" value="-329.24" spread="646.985"/>
                    <measurement group_id="O7" value="-251.73" spread="243.794"/>
                    <measurement group_id="O8" value="-497.35" spread="725.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-396.21" spread="675.761"/>
                    <measurement group_id="O2" value="-373.86" spread="702.530"/>
                    <measurement group_id="O3" value="-249.26" spread="655.999"/>
                    <measurement group_id="O4" value="-118.86" spread="900.798"/>
                    <measurement group_id="O5" value="-293.94" spread="685.681"/>
                    <measurement group_id="O6" value="-433.08" spread="761.573"/>
                    <measurement group_id="O7" value="9.89" spread="523.754"/>
                    <measurement group_id="O8" value="-229.56" spread="809.850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-541.36" spread="773.006"/>
                    <measurement group_id="O2" value="-409.53" spread="751.624"/>
                    <measurement group_id="O3" value="-140.60" spread="1358.127"/>
                    <measurement group_id="O4" value="-76.20" spread="993.110"/>
                    <measurement group_id="O5" value="-390.21" spread="717.114"/>
                    <measurement group_id="O6" value="-434.36" spread="659.528"/>
                    <measurement group_id="O7" value="-379.06" spread="244.917"/>
                    <measurement group_id="O8" value="-552.55" spread="824.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-202.07" spread="799.169"/>
                    <measurement group_id="O2" value="-91.61" spread="2254.397"/>
                    <measurement group_id="O3" value="-321.73" spread="600.297"/>
                    <measurement group_id="O4" value="-361.73" spread="782.881"/>
                    <measurement group_id="O5" value="-476.86" spread="716.072"/>
                    <measurement group_id="O6" value="-556.69" spread="1288.342"/>
                    <measurement group_id="O7" value="-343.64" spread="377.590"/>
                    <measurement group_id="O8" value="-706.11" spread="1111.877"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72</title>
        <description>Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.&#xD;
Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).&#xD;
The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.&#xD;
A score of 0 represents &quot;I am not breathless at all&quot; and 10 represents &quot;I am the most breathless I can possibly imagine&quot;.</description>
        <time_frame>Hours 6, 12, 24, 48, and 72</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72</title>
          <description>Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.&#xD;
Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).&#xD;
The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.&#xD;
A score of 0 represents &quot;I am not breathless at all&quot; and 10 represents &quot;I am the most breathless I can possibly imagine&quot;.</description>
          <population>All treated participants</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="66"/>
                    <count group_id="O5" value="68"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="1.84"/>
                    <measurement group_id="O2" value="-1.5" spread="1.64"/>
                    <measurement group_id="O3" value="-1.1" spread="1.90"/>
                    <measurement group_id="O4" value="-1.7" spread="1.94"/>
                    <measurement group_id="O5" value="-1.7" spread="2.13"/>
                    <measurement group_id="O6" value="-0.3" spread="1.03"/>
                    <measurement group_id="O7" value="0.0" spread="2.90"/>
                    <measurement group_id="O8" value="-1.3" spread="3.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="64"/>
                    <count group_id="O5" value="66"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="2.38"/>
                    <measurement group_id="O2" value="-2.2" spread="1.73"/>
                    <measurement group_id="O3" value="-1.7" spread="2.75"/>
                    <measurement group_id="O4" value="-2.4" spread="2.38"/>
                    <measurement group_id="O5" value="-2.0" spread="2.49"/>
                    <measurement group_id="O6" value="-1.0" spread="1.79"/>
                    <measurement group_id="O7" value="-0.2" spread="3.37"/>
                    <measurement group_id="O8" value="-1.4" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="67"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="2.50"/>
                    <measurement group_id="O2" value="-2.1" spread="2.19"/>
                    <measurement group_id="O3" value="-2.1" spread="2.82"/>
                    <measurement group_id="O4" value="-2.9" spread="2.68"/>
                    <measurement group_id="O5" value="-2.2" spread="2.42"/>
                    <measurement group_id="O6" value="-0.8" spread="1.72"/>
                    <measurement group_id="O7" value="-1.5" spread="3.02"/>
                    <measurement group_id="O8" value="-1.2" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="68"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="2.15"/>
                    <measurement group_id="O2" value="-2.6" spread="2.51"/>
                    <measurement group_id="O3" value="-2.8" spread="3.00"/>
                    <measurement group_id="O4" value="-3.4" spread="2.44"/>
                    <measurement group_id="O5" value="-2.8" spread="2.45"/>
                    <measurement group_id="O6" value="-1.2" spread="1.47"/>
                    <measurement group_id="O7" value="-0.8" spread="3.43"/>
                    <measurement group_id="O8" value="-2.0" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="68"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="2.23"/>
                    <measurement group_id="O2" value="-3.7" spread="2.22"/>
                    <measurement group_id="O3" value="-3.2" spread="3.19"/>
                    <measurement group_id="O4" value="-3.9" spread="2.28"/>
                    <measurement group_id="O5" value="-3.2" spread="2.73"/>
                    <measurement group_id="O6" value="-1.2" spread="2.14"/>
                    <measurement group_id="O7" value="-1.2" spread="3.19"/>
                    <measurement group_id="O8" value="-2.0" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion</title>
        <description>The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.</description>
        <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion</title>
          <description>The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.05" upper_limit="11.07"/>
                    <measurement group_id="O2" value="6.1" lower_limit="1.28" upper_limit="16.87"/>
                    <measurement group_id="O3" value="1.4" lower_limit="0.04" upper_limit="7.60"/>
                    <measurement group_id="O4" value="2.8" lower_limit="0.34" upper_limit="9.81"/>
                    <measurement group_id="O5" value="8.3" lower_limit="3.12" upper_limit="17.26"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O8" value="0" lower_limit="0.00" upper_limit="45.93"/>
                  </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>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>2.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>75.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>54.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), symptoms of hypotension - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>5.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>149.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), symptoms of hypotension - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SBP &lt; 90 mm Hg (Confirmed by a Repeated Value)</title>
        <description>The percentage of participants experiencing SBP &lt; 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.</description>
        <time_frame>From start of infusion up to 6 hours post end of infusion</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SBP &lt; 90 mm Hg (Confirmed by a Repeated Value)</title>
          <description>The percentage of participants experiencing SBP &lt; 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="1.31" upper_limit="17.20"/>
                    <measurement group_id="O2" value="20.4" lower_limit="10.24" upper_limit="34.34"/>
                    <measurement group_id="O3" value="18.3" lower_limit="10.13" upper_limit="29.27"/>
                    <measurement group_id="O4" value="21.1" lower_limit="12.33" upper_limit="32.44"/>
                    <measurement group_id="O5" value="29.2" lower_limit="19.05" upper_limit="41.07"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="33.3" lower_limit="4.33" upper_limit="77.72"/>
                    <measurement group_id="O8" value="50.0" lower_limit="11.81" upper_limit="88.19"/>
                  </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>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>3.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>14.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part I, confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (low dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), confirmed SBP &lt; 90 mmHg - relative risk</non_inferiority_desc>
            <param_type>Relative risk from placebo</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>3.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II (high dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (low dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Part II-Japan (high dose), confirmed SBP &lt; 90 mmHg - relative difference</non_inferiority_desc>
            <param_type>Relative difference from placebo</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32</title>
        <description>Number of participants who experienced an in-study SAE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.</description>
        <time_frame>32 days</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32</title>
          <description>Number of participants who experienced an in-study SAE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Due to Hypotension</title>
        <description>Number of participants who discontinued study treatment due to hypotension.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
Hypotension defined as systolic blood pressure (SBP) &lt; 90 mmHg.</description>
        <time_frame>up to 120 hours (for AEs); up to 32 days (for SAEs)</time_frame>
        <population>All treated participants&#xD;
Note: Discontinuation due to hypotension occurred per protocol-mandated lowering of blood pressure to &lt; 90 mmHg.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Due to Hypotension</title>
          <description>Number of participants who discontinued study treatment due to hypotension.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
Hypotension defined as systolic blood pressure (SBP) &lt; 90 mmHg.</description>
          <population>All treated participants&#xD;
Note: Discontinuation due to hypotension occurred per protocol-mandated lowering of blood pressure to &lt; 90 mmHg.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure</title>
        <description>Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
If the participant experienced systolic blood pressure (SBP) &lt; 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained &lt; 95 mm Hg, the dose reduction occurred.</description>
        <time_frame>up to 120 hours (for AEs); up to 32 days (for SAEs)</time_frame>
        <population>All treated participants&#xD;
Note: Discontinuation due to decreased blood pressure occurred per protocol-mandated lowering of blood pressure to &lt; 95 mmHg.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure</title>
          <description>Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.&#xD;
If the participant experienced systolic blood pressure (SBP) &lt; 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained &lt; 95 mm Hg, the dose reduction occurred.</description>
          <population>All treated participants&#xD;
Note: Discontinuation due to decreased blood pressure occurred per protocol-mandated lowering of blood pressure to &lt; 95 mmHg.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>down-titration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="25"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours</title>
        <description>Number of participants who experienced an in-study AE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.</description>
        <time_frame>up to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours</title>
          <description>Number of participants who experienced an in-study AE.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="48"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182</title>
        <description>Number of participants who died (all- cause and CV related) through Day 182.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
CV=Cardiovascular</description>
        <time_frame>through 182 days</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182</title>
          <description>Number of participants who died (all- cause and CV related) through Day 182.&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0&#xD;
CV=Cardiovascular</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.31" upper_limit="17.20"/>
                    <measurement group_id="O2" value="3" lower_limit="1.28" upper_limit="16.87"/>
                    <measurement group_id="O3" value="11" lower_limit="8.00" upper_limit="26.03"/>
                    <measurement group_id="O4" value="12" lower_limit="9.05" upper_limit="27.66"/>
                    <measurement group_id="O5" value="9" lower_limit="5.88" upper_limit="22.41"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O8" value="1" lower_limit="0.42" upper_limit="64.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CV-related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.31" upper_limit="17.20"/>
                    <measurement group_id="O2" value="2" lower_limit="0.50" upper_limit="13.98"/>
                    <measurement group_id="O3" value="9" lower_limit="5.96" upper_limit="22.70"/>
                    <measurement group_id="O4" value="10" lower_limit="6.97" upper_limit="24.38"/>
                    <measurement group_id="O5" value="4" lower_limit="1.53" upper_limit="13.62"/>
                    <measurement group_id="O6" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O7" value="0" lower_limit="0.00" upper_limit="45.93"/>
                    <measurement group_id="O8" value="0" lower_limit="0.00" upper_limit="45.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Troponin T From Baseline to Hour 24, 48, and 72</title>
        <description>Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug</description>
        <time_frame>from baseline to Hour 24, 48, and 72</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Troponin T From Baseline to Hour 24, 48, and 72</title>
          <description>Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug</description>
          <population>All treated participants</population>
          <units>ng/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="66"/>
                    <count group_id="O5" value="68"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="27.303"/>
                    <measurement group_id="O2" value="-1.31" spread="12.278"/>
                    <measurement group_id="O3" value="-1.80" spread="11.266"/>
                    <measurement group_id="O4" value="-3.45" spread="20.030"/>
                    <measurement group_id="O5" value="-8.09" spread="37.864"/>
                    <measurement group_id="O6" value="-4.67" spread="3.983"/>
                    <measurement group_id="O7" value="1.33" spread="5.750"/>
                    <measurement group_id="O8" value="-7.67" spread="16.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="44"/>
                    <count group_id="O3" value="64"/>
                    <count group_id="O4" value="63"/>
                    <count group_id="O5" value="68"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="22.714"/>
                    <measurement group_id="O2" value="14.56" spread="81.979"/>
                    <measurement group_id="O3" value="-2.88" spread="16.424"/>
                    <measurement group_id="O4" value="8.08" spread="71.672"/>
                    <measurement group_id="O5" value="-11.15" spread="45.495"/>
                    <measurement group_id="O6" value="-10.67" spread="10.633"/>
                    <measurement group_id="O7" value="49.50" spread="118.417"/>
                    <measurement group_id="O8" value="-8.40" spread="25.501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="57"/>
                    <count group_id="O5" value="65"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.07" spread="30.033"/>
                    <measurement group_id="O2" value="6.76" spread="66.673"/>
                    <measurement group_id="O3" value="-1.44" spread="16.472"/>
                    <measurement group_id="O4" value="5.00" spread="65.766"/>
                    <measurement group_id="O5" value="-13.05" spread="68.276"/>
                    <measurement group_id="O6" value="-10.50" spread="12.145"/>
                    <measurement group_id="O7" value="248.00" spread="433.581"/>
                    <measurement group_id="O8" value="-15.00" spread="25.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology</title>
        <description>Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology</title>
          <description>Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>high leukocyte counts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low hemoglobin values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low platelet values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low neutrophils values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low leukocyte counts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low hematocrit values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low erythrocytes values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry</title>
        <description>Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry</title>
          <description>Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>high blood urea nitrogen values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="23"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high urate values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high potassium values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high alanine aminotransferase (ALT) values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high alkaline phosphatase values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low protein values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high asparate aminotransferase values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high bilirubin values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high bicarbonate values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low chloride counts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high creatine kinase values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high protein values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high sodium values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low bicarbonate values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low sodium values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low albumin values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low calcium values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis</title>
        <description>Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis</title>
          <description>Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in &gt; 5% of total participants).&#xD;
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>high protein values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="64"/>
                    <count group_id="O5" value="69"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high erythrocyte values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="50"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high leukocytes values</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="50"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vital Signs From Baseline to 120 Hours - Blood Pressure</title>
        <description>The change in baseline for vital signs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants with a 120-hour evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vital Signs From Baseline to 120 Hours - Blood Pressure</title>
          <description>The change in baseline for vital signs was reported for each arm.</description>
          <population>All treated participants with a 120-hour evaluation</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>systolic blood pressure, mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="16.60"/>
                    <measurement group_id="O2" value="0.0" spread="17.75"/>
                    <measurement group_id="O3" value="-4.3" spread="15.23"/>
                    <measurement group_id="O4" value="-7.9" spread="15.60"/>
                    <measurement group_id="O5" value="-8.8" spread="14.01"/>
                    <measurement group_id="O6" value="-10.3" spread="15.60"/>
                    <measurement group_id="O7" value="-17.5" spread="9.14"/>
                    <measurement group_id="O8" value="-6.2" spread="16.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>diastolic blood pressure, mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="12.67"/>
                    <measurement group_id="O2" value="-1.9" spread="13.53"/>
                    <measurement group_id="O3" value="-4.4" spread="12.99"/>
                    <measurement group_id="O4" value="-3.4" spread="14.37"/>
                    <measurement group_id="O5" value="-1.6" spread="10.83"/>
                    <measurement group_id="O6" value="1.7" spread="16.24"/>
                    <measurement group_id="O7" value="-15.7" spread="19.08"/>
                    <measurement group_id="O8" value="-9.3" spread="14.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vital Signs From Baseline to 120 Hours - Heart Rate</title>
        <description>The change in baseline for vital signs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vital Signs From Baseline to 120 Hours - Heart Rate</title>
          <description>The change in baseline for vital signs was reported for each arm.</description>
          <population>All treated participants</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="15.53"/>
                    <measurement group_id="O2" value="-9.1" spread="17.13"/>
                    <measurement group_id="O3" value="-8.3" spread="15.55"/>
                    <measurement group_id="O4" value="-4.6" spread="15.40"/>
                    <measurement group_id="O5" value="-6.3" spread="15.60"/>
                    <measurement group_id="O6" value="-6.7" spread="21.88"/>
                    <measurement group_id="O7" value="-3.0" spread="13.31"/>
                    <measurement group_id="O8" value="3.8" spread="11.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate</title>
        <description>The change in baseline for vital signs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate</title>
          <description>The change in baseline for vital signs was reported for each arm.</description>
          <population>All treated participants</population>
          <units>breaths/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="3.93"/>
                    <measurement group_id="O2" value="-3.0" spread="4.82"/>
                    <measurement group_id="O3" value="-2.9" spread="3.80"/>
                    <measurement group_id="O4" value="-2.6" spread="4.33"/>
                    <measurement group_id="O5" value="-1.8" spread="3.96"/>
                    <measurement group_id="O6" value="-2.3" spread="2.88"/>
                    <measurement group_id="O7" value="0.0" spread="9.98"/>
                    <measurement group_id="O8" value="-1.4" spread="3.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vital Signs From Baseline to 120 Hours - Temperature</title>
        <description>The change in baseline for vital signs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vital Signs From Baseline to 120 Hours - Temperature</title>
          <description>The change in baseline for vital signs was reported for each arm.</description>
          <population>All treated participants</population>
          <units>degrees C</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.643"/>
                    <measurement group_id="O2" value="0.09" spread="0.649"/>
                    <measurement group_id="O3" value="0.04" spread="0.427"/>
                    <measurement group_id="O4" value="0.00" spread="0.342"/>
                    <measurement group_id="O5" value="-0.05" spread="0.481"/>
                    <measurement group_id="O6" value="-0.47" spread="0.650"/>
                    <measurement group_id="O7" value="-0.27" spread="0.535"/>
                    <measurement group_id="O8" value="0.44" spread="0.541"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate</title>
        <description>The change in baseline for ECGs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate</title>
          <description>The change in baseline for ECGs was reported for each arm.</description>
          <population>All treated participants</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="9.36"/>
                    <measurement group_id="O2" value="-6.8" spread="21.31"/>
                    <measurement group_id="O3" value="-7.1" spread="17.46"/>
                    <measurement group_id="O4" value="-5.1" spread="18.64"/>
                    <measurement group_id="O5" value="-6.1" spread="17.33"/>
                    <measurement group_id="O6" value="2.0" spread="10.72"/>
                    <measurement group_id="O7" value="-13.0" spread="12.62"/>
                    <measurement group_id="O8" value="-5.2" spread="14.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration</title>
        <description>The change in baseline for ECGs was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration</title>
          <description>The change in baseline for ECGs was reported for each arm.</description>
          <population>All treated participants</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR Interval, Aggregate, msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="5"/>
                    <count group_id="O8" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.4" spread="66.31"/>
                    <measurement group_id="O2" value="-2.3" spread="32.11"/>
                    <measurement group_id="O3" value="-0.1" spread="23.49"/>
                    <measurement group_id="O4" value="10.9" spread="22.02"/>
                    <measurement group_id="O5" value="2.0" spread="25.41"/>
                    <measurement group_id="O6" value="-1.5" spread="16.50"/>
                    <measurement group_id="O7" value="10.4" spread="26.32"/>
                    <measurement group_id="O8" value="6.0" spread="30.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration, Aggregate, msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="22.19"/>
                    <measurement group_id="O2" value="-0.1" spread="12.46"/>
                    <measurement group_id="O3" value="1.6" spread="20.29"/>
                    <measurement group_id="O4" value="-1.6" spread="13.22"/>
                    <measurement group_id="O5" value="2.7" spread="16.77"/>
                    <measurement group_id="O6" value="-3.0" spread="4.80"/>
                    <measurement group_id="O7" value="-2.5" spread="7.20"/>
                    <measurement group_id="O8" value="3.0" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval, Aggregate, msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.6" spread="49.20"/>
                    <measurement group_id="O2" value="7.2" spread="48.25"/>
                    <measurement group_id="O3" value="8.7" spread="53.17"/>
                    <measurement group_id="O4" value="5.8" spread="42.19"/>
                    <measurement group_id="O5" value="-0.3" spread="45.39"/>
                    <measurement group_id="O6" value="-30.0" spread="28.17"/>
                    <measurement group_id="O7" value="5.7" spread="24.41"/>
                    <measurement group_id="O8" value="16.5" spread="50.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, Aggregate, msec</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="44"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.5" spread="41.79"/>
                    <measurement group_id="O2" value="-13.9" spread="41.56"/>
                    <measurement group_id="O3" value="-4.0" spread="51.04"/>
                    <measurement group_id="O4" value="-4.0" spread="33.59"/>
                    <measurement group_id="O5" value="-10.3" spread="37.63"/>
                    <measurement group_id="O6" value="-24.8" spread="20.00"/>
                    <measurement group_id="O7" value="-8.8" spread="22.35"/>
                    <measurement group_id="O8" value="3.2" spread="22.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Measurements From Baseline to 120 Hours</title>
        <description>The change in baseline for physical measurements was reported for each arm.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O6">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O7">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O8">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Measurements From Baseline to 120 Hours</title>
          <description>The change in baseline for physical measurements was reported for each arm.</description>
          <population>All treated participants</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0383"/>
                    <measurement group_id="O2" value="0.10" spread="0.285"/>
                    <measurement group_id="O3" value="-2.87" spread="4.447"/>
                    <measurement group_id="O4" value="-2.96" spread="4.231"/>
                    <measurement group_id="O5" value="-1.83" spread="5.295"/>
                    <measurement group_id="O6" value="-3.58" spread="2.182"/>
                    <measurement group_id="O7" value="-3.97" spread="2.160"/>
                    <measurement group_id="O8" value="-6.08" spread="4.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants with a 120-hour evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants with a 120-hour evaluation</population>
          <units>x10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="41"/>
                <count group_id="O4" value="36"/>
                <count group_id="O5" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>leukocyte, x10^9 c/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="36"/>
                    <count group_id="O5" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="3.078"/>
                    <measurement group_id="O2" value="-1.38" spread="1.892"/>
                    <measurement group_id="O3" value="-0.20" spread="4.370"/>
                    <measurement group_id="O4" value="0.20" spread="2.549"/>
                    <measurement group_id="O5" value="-0.09" spread="1.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>platelet, x10^9 c/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="38"/>
                    <count group_id="O4" value="34"/>
                    <count group_id="O5" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.63" spread="31.679"/>
                    <measurement group_id="O2" value="-5.77" spread="34.666"/>
                    <measurement group_id="O3" value="1.84" spread="40.808"/>
                    <measurement group_id="O4" value="3.26" spread="37.888"/>
                    <measurement group_id="O5" value="1.26" spread="31.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants with a 120-hour evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants with a 120-hour evaluation</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hemoglobin, g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="36"/>
                    <count group_id="O5" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="11.851"/>
                    <measurement group_id="O2" value="-0.70" spread="8.573"/>
                    <measurement group_id="O3" value="1.20" spread="11.487"/>
                    <measurement group_id="O4" value="0.94" spread="11.684"/>
                    <measurement group_id="O5" value="1.38" spread="9.161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>protein, g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="6.172"/>
                    <measurement group_id="O2" value="2.77" spread="5.839"/>
                    <measurement group_id="O3" value="0.57" spread="8.178"/>
                    <measurement group_id="O4" value="0.38" spread="6.048"/>
                    <measurement group_id="O5" value="-0.05" spread="5.367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>blood urea nitrogen, mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.01" spread="5.474"/>
                    <measurement group_id="O2" value="0.32" spread="3.164"/>
                    <measurement group_id="O3" value="1.96" spread="3.920"/>
                    <measurement group_id="O4" value="2.15" spread="5.016"/>
                    <measurement group_id="O5" value="1.24" spread="3.655"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>urate, mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.154"/>
                    <measurement group_id="O2" value="0.01" spread="0.108"/>
                    <measurement group_id="O3" value="-0.01" spread="0.126"/>
                    <measurement group_id="O4" value="0.04" spread="0.147"/>
                    <measurement group_id="O5" value="-0.03" spread="0.111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>potassium, mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="46"/>
                    <count group_id="O5" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.697"/>
                    <measurement group_id="O2" value="0.28" spread="0.513"/>
                    <measurement group_id="O3" value="0.21" spread="0.692"/>
                    <measurement group_id="O4" value="0.13" spread="0.558"/>
                    <measurement group_id="O5" value="0.15" spread="0.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>alanine aminotransferase (ALT), U/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.13" spread="837.833"/>
                    <measurement group_id="O2" value="-2.73" spread="11.089"/>
                    <measurement group_id="O3" value="-3.22" spread="102.038"/>
                    <measurement group_id="O4" value="30.36" spread="189.310"/>
                    <measurement group_id="O5" value="-13.07" spread="76.357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>alkaline phosphatase, U/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="44"/>
                    <count group_id="O5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="28.018"/>
                    <measurement group_id="O2" value="1.65" spread="11.052"/>
                    <measurement group_id="O3" value="-1.31" spread="25.186"/>
                    <measurement group_id="O4" value="5.43" spread="26.007"/>
                    <measurement group_id="O5" value="-0.49" spread="21.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>asparate aminotransferase, U/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="43"/>
                    <count group_id="O5" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.77" spread="1204.410"/>
                    <measurement group_id="O2" value="-2.77" spread="10.277"/>
                    <measurement group_id="O3" value="-11.15" spread="127.903"/>
                    <measurement group_id="O4" value="10.81" spread="65.009"/>
                    <measurement group_id="O5" value="-10.00" spread="52.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">120 hour data not collected</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">120 hour data not collected</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">120 hour data not collected</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">120 hour data not collected</measurement>
                    <measurement group_id="O5" value="NA" spread="NA">120 hour data not collected</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part I</title>
            <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 - Part I</title>
            <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Part II</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O4">
            <title>BMS-986231 6 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
          </group>
          <group group_id="O5">
            <title>BMS-986231 12 µg/kg/Min - Part II</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.</description>
          <population>All treated participants</population>
          <units>x10^12 c/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="71"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.394"/>
                    <measurement group_id="O2" value="0.02" spread="0.305"/>
                    <measurement group_id="O3" value="0.04" spread="0.409"/>
                    <measurement group_id="O4" value="0.04" spread="0.481"/>
                    <measurement group_id="O5" value="0.09" spread="0.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O3">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
          <population>All treated participants</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.38" spread="192.568"/>
                    <measurement group_id="O2" value="74.13" spread="110.919"/>
                    <measurement group_id="O3" value="131.64" spread="407.611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O3">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
          <population>All treated participants</population>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="17.728"/>
                    <measurement group_id="O2" value="-1.50" spread="6.775"/>
                    <measurement group_id="O3" value="12.40" spread="23.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O3">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
          <population>All treated participants</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.268"/>
                    <measurement group_id="O2" value="0.17" spread="0.150"/>
                    <measurement group_id="O3" value="0.25" spread="0.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O3">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
          <population>All treated participants</population>
          <units>Fractional Potassium Excretion percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.88" spread="8.009"/>
                    <measurement group_id="O2" value="-1.22" spread="4.926"/>
                    <measurement group_id="O3" value="-12.34" spread="13.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion</title>
        <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
        <time_frame>to 120 hours</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Part II (Japan Cohort)</title>
            <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O2">
            <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
          <group group_id="O3">
            <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
            <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion</title>
          <description>The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.</description>
          <population>All treated participants</population>
          <units>Fractional Sodium Excretion percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="2.076"/>
                    <measurement group_id="O2" value="-2.62" spread="4.538"/>
                    <measurement group_id="O3" value="-5.50" spread="7.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Includes non-serious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Mortality data reported through 182 days post-treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo - Part I</title>
          <description>Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="E2">
          <title>BMS-986231 - Part I</title>
          <description>Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours)</description>
        </group>
        <group group_id="E3">
          <title>Placebo - Part II</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="E4">
          <title>BMS-986231 6 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="E5">
          <title>BMS-986231 12 µg/kg/Min - Part II</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours</description>
        </group>
        <group group_id="E6">
          <title>Placebo - Part II (Japan Cohort)</title>
          <description>Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="E7">
          <title>BMS-986231 6 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
        <group group_id="E8">
          <title>BMS-986231 12 µg/kg/Min - Part II (Japan Cohort)</title>
          <description>BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants</description>
        </group>
      </group_list>
      <serious_events>
        <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, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="15" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIOGENIC SHOCK</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIORENAL SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK COMPLETE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY STENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>VENTRICULAR FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CHRONIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>SINUS BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>VENTRICULAR ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>VENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL ISCHAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</sub_title>
                <description>GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATIC CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ACINETOBACTER BACTERAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ERYSIPELAS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>WRIST FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERNATRAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>FLUID OVERLOAD</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>BLADDER CANCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ALTERED STATE OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ORGANIC BRAIN SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>BLADDER MASS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>END STAGE RENAL DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY DISTRESS SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>HYPERCAPNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>SLEEP APNOEA SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ACUTE PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ANGIOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ILIAC ARTERY OCCLUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERY OCCLUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </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="18" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="47" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="54" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>VENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL ISCHAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VITREOUS DETACHMENT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERURICAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>RENAL IMPAIRMENT</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH PRURITIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="71"/>
                <counts group_id="E5" subjects_affected="31" subjects_at_risk="72"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email:</phone>
      <email>Clinical.Trials@bms.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/NCT03016325
org study id: CV013-011
secondary id: 2016-001685-29
nct id: NCT03016325
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO
      Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion
time frame: From start of infusion up to 6 hours post end of infusion
description: Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) < 90 mm Hg (confirmed by a repeated value < 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
measure: Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32
time frame: 0, 24, 48, 72, 120 hour or discharge; Day 32
description: Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)
measure: Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72
time frame: Hours 6, 12, 24, 48, and 72
description: Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.
Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).
The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.
A score of 0 represents "I am not breathless at all" and 10 represents "I am the most breathless I can possibly imagine".
measure: Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion
time frame: From start of infusion up to 6 hours post end of infusion
description: The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.
measure: Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)
time frame: From start of infusion up to 6 hours post end of infusion
description: The percentage of participants experiencing SBP < 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.
measure: Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32
time frame: 32 days
description: Number of participants who experienced an in-study SAE.
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.
measure: Number of Participants Who Discontinued Due to Hypotension
time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)
description: Number of participants who discontinued study treatment due to hypotension.
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.
Hypotension defined as systolic blood pressure (SBP) < 90 mmHg.
measure: Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure
time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)
description: Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.
If the participant experienced systolic blood pressure (SBP) < 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained < 95 mm Hg, the dose reduction occurred.
measure: Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours
time frame: up to 120 hours
description: Number of participants who experienced an in-study AE.
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.
measure: Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182
time frame: through 182 days
description: Number of participants who died (all- cause and CV related) through Day 182.
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
CV=Cardiovascular
measure: Change in Troponin T From Baseline to Hour 24, 48, and 72
time frame: from baseline to Hour 24, 48, and 72
description: Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug
measure: Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology
time frame: to 120 hours
description: Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in > 5% of total participants).
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
measure: Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry
time frame: to 120 hours
description: Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in > 5% of total participants).
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
measure: Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis
time frame: to 120 hours
description: Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in > 5% of total participants).
Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
measure: Change in Vital Signs From Baseline to 120 Hours - Blood Pressure
time frame: to 120 hours
description: The change in baseline for vital signs was reported for each arm.
measure: Change in Vital Signs From Baseline to 120 Hours - Heart Rate
time frame: to 120 hours
description: The change in baseline for vital signs was reported for each arm.
measure: Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate
time frame: to 120 hours
description: The change in baseline for vital signs was reported for each arm.
measure: Change in Vital Signs From Baseline to 120 Hours - Temperature
time frame: to 120 hours
description: The change in baseline for vital signs was reported for each arm.
measure: Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate
time frame: to 120 hours
description: The change in baseline for ECGs was reported for each arm.
measure: Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration
time frame: to 120 hours
description: The change in baseline for ECGs was reported for each arm.
measure: Change in Physical Measurements From Baseline to 120 Hours
time frame: to 120 hours
description: The change in baseline for physical measurements was reported for each arm.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
measure: Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion
time frame: to 120 hours
description: The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
arm group label: Part 1 Cohort 1 HNO Donor
arm group type: Experimental
arm group label: Placebo Part 1 Cohort 1
arm group type: Placebo Comparator
arm group label: Part 2 Cohort 2 HNO Donor- low dose
arm group type: Experimental
arm group label: Part 2 Cohort 2 HNO Donor- high dose
arm group type: Experimental
arm group label: Placebo Part 2 Cohort 2
arm group type: Placebo Comparator
intervention type: Drug
intervention name: HNO Donor
description: Infusion
arm group label: Part 1 Cohort 1 HNO Donor
arm group label: Part 2 Cohort 2 HNO Donor- high dose
arm group label: Part 2 Cohort 2 HNO Donor- low dose
other name: BMS-986231
intervention type: Drug
intervention name: Placebo
description: Infusion
arm group label: Placebo Part 1 Cohort 1
arm group label: Placebo Part 2 Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Canada
country: Czechia
country: France
country: Germany
country: Greece
country: Italy
country: Japan
country: Netherlands
country: Poland
country: Spain
country: United Kingdom
country: United States
country: Czech Republic
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Heart Failure
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 