<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/NCT03252587</url>
  </required_header>
  <id_info>
    <org_study_id>IM011-021</org_study_id>
    <secondary_id>2017-001203-79</secondary_id>
    <nct_id>NCT03252587</nct_id>
  </id_info>
  <brief_title>An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus</brief_title>
  <official_title>A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus</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>
      This study will investigate BMS-986165 to assess its effects in participants with systemic&#xD;
      lupus erythematosus (SLE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">October 28, 2021</completion_date>
  <primary_completion_date type="Actual">June 29, 2021</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>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32</measure>
    <time_frame>At week 32</time_frame>
    <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48</measure>
    <time_frame>At week 48</time_frame>
    <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response</measure>
    <time_frame>At week 48</time_frame>
    <description>BICLA responder is defined as a patient whose disease course fulfills all of the following:&#xD;
Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline&#xD;
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B&#xD;
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)&#xD;
No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)</measure>
    <time_frame>At Week 48</time_frame>
    <description>LLDAS is defined as follows:&#xD;
SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System&#xD;
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters&#xD;
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily&#xD;
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10</measure>
    <time_frame>At week 48</time_frame>
    <description>Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the 40-Joint Count</measure>
    <time_frame>Baseline and week 48</time_frame>
    <description>Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:&#xD;
Tender joint count (0 to 40)&#xD;
Swollen joint count (0 to 40)&#xD;
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
    <description>Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities in Specific Liver Tests</measure>
    <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
    <description>Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:&#xD;
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation &gt; 3× Upper Limit of Normal (ULN)&#xD;
Total bilirubin &gt; 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)&#xD;
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormalities in Vital Signs</measure>
    <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
    <description>Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormalities in Electrocardiograms (ECGs)</measure>
    <time_frame>From baseline to up to week 48</time_frame>
    <description>Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12</time_frame>
    <description>Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12</time_frame>
    <description>Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)</measure>
    <time_frame>Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48</time_frame>
    <description>Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels</measure>
    <time_frame>From baseline to week 44</time_frame>
    <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32</measure>
    <time_frame>From baseline to week 32</time_frame>
    <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Complement Proteins C3 and C4 Levels</measure>
    <time_frame>From baseline to week 52</time_frame>
    <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Complement (C3, C4) Levels at Week 32</measure>
    <time_frame>From baseline to week 32</time_frame>
    <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels</measure>
    <time_frame>From baseline to week 52</time_frame>
    <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32</measure>
    <time_frame>From baseline to week 32</time_frame>
    <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status</measure>
    <time_frame>At week 32</time_frame>
    <description>Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">363</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>BMS-986165 Dose 1 oral administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BMS-986165 Dose 2 oral administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BMS-986165 Dose 3 oral administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oral administration</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986165</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>BMS-986165 Dose 1 oral administration</arm_group_label>
    <arm_group_label>BMS-986165 Dose 2 oral administration</arm_group_label>
    <arm_group_label>BMS-986165 Dose 3 oral administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Placebo oral administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening&#xD;
             visit&#xD;
&#xD;
          -  Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification&#xD;
             criteria for SLE&#xD;
&#xD;
          -  One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti-&#xD;
             double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate&#xD;
             results) or positive anti-Smith (anti-Sm) as determined by the central laboratory&#xD;
&#xD;
          -  Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6&#xD;
             points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash&#xD;
             [score must be confirmed by Central Review Services (CRS)]&#xD;
&#xD;
          -  Men and women must agree to follow specific methods of contraception, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus&#xD;
             nephritis&#xD;
&#xD;
          -  SLE overlap syndromes such as scleroderma and mixed connective tissue disease&#xD;
&#xD;
          -  Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)&#xD;
&#xD;
          -  History of any significant drug allergy&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</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>Local Institution - 0178</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Little Rock Diagnostic Clinic</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioSolutions Clinical Research Center</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County Hospital and University of Southern California Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at Irvine College of Medicine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0227</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Clinical Trials - Thousand Oaks</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lundquist Institute at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Rheumatology Clinical Trials</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0034</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030-5353</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0195</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520-8018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0066</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0214</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0233</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0057</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174-1139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BayCare Medical Group</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0206</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0083</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Research and Treatment Center</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klein &amp; Associates</name>
      <address>
        <city>Cumberland</city>
        <state>Maryland</state>
        <zip>21502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klein and Associates</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Rheumatology - Lansing</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455-0341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Downstate Health Science University</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0082</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0109</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0232</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0119</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0180</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0197</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0174</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0190</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731-3146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0086</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429-5890</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0193</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0204</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0047</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis and Osteoporosis Center of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0171</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320-4985</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Northwest, PLLC</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0166</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1114AAF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0139</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>1430</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0185</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1046AAQ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0136</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1111AAL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0138</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1425AGC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0152</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000PBJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0097</name>
      <address>
        <city>San Miguel De Tucum</city>
        <state>Tucuman</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0096</name>
      <address>
        <city>Cordoba</city>
        <zip>X5004FHP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado Centro Medico de Cordoba</name>
      <address>
        <city>Cordoba</city>
        <zip>X5016KEH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0137</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0241</name>
      <address>
        <city>Maroochydore</city>
        <state>Queensland</state>
        <zip>4558</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heidelberg Repatriation Hospital</name>
      <address>
        <city>Heidelberg West</city>
        <state>Victoria</state>
        <zip>3081</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0130</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40150150</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0129</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <zip>74110-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Belo Horizonte</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30150-223</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>Juiz de Fora</city>
        <state>Minas Gerais</state>
        <zip>36010-570</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0126</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80030-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0128</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90480-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>SAO Paulo</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0151</name>
      <address>
        <city>Sao Bernardo do Campo</city>
        <state>SAO Paulo</state>
        <zip>09715-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITIPA - Centro de Imunoterapia de Ipanema</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22221-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0148</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01228-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0247</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0245</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0098</name>
      <address>
        <city>Barranquilla</city>
        <zip>080002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0099</name>
      <address>
        <city>Barranquilla</city>
        <zip>0</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicity SAS</name>
      <address>
        <city>Bucaramanga</city>
        <zip>680003</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0161</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0100</name>
      <address>
        <city>Chia</city>
        <zip>250001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0159</name>
      <address>
        <city>Zipaquira</city>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi</name>
      <address>
        <city>Berlin</city>
        <zip>D-10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik fur Nieren- und Hochdruckerkrankungen</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0035</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0123</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>33394</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Jerusalem</city>
        <zip>9122001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tel-Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0117</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8712</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kameda Clinic</name>
      <address>
        <city>Kamogawa-shi</city>
        <state>Chiba</state>
        <zip>296-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0177</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>807-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0141</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0608604</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai City</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomishiro Central Hospital</name>
      <address>
        <city>Tomigusuku-shi</city>
        <state>Okinawa</state>
        <zip>9010243</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University</name>
      <address>
        <city>Shimotsuga-gun</city>
        <state>Tochigi</state>
        <zip>3210293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0183</name>
      <address>
        <city>Shimotsuke-city</city>
        <state>Tochigi</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0154</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0144</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>1738610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0162</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>152-8902</zip>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0133</name>
      <address>
        <city>Tokyo</city>
        <zip>162-8655</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Daegu</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Daejeon</city>
        <zip>35015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0253</name>
      <address>
        <city>Gwangju</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Incheon</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0054</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0050</name>
      <address>
        <city>Suwon</city>
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        <country>Korea, Republic of</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0140</name>
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        <city>Mexico City</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0173</name>
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        <city>Mexico</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0163</name>
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        <city>Leon, Guanajuato</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0172</name>
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        <city>Leon</city>
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      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0135</name>
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        <city>Guadalajara</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0156</name>
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        <city>Zapopan</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Juan Alberto Rodriguez Ruiz</name>
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        <city>Zapopan</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0134</name>
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        <city>Monterrey</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0149</name>
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        <city>San Luis Potosi</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Faicic S. de R.L. de C.V.</name>
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  <location>
    <facility>
      <name>Local Institution - 0089</name>
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  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C</name>
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  <location>
    <facility>
      <name>Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska</name>
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  <location>
    <facility>
      <name>Centrum Medyczne Pratia w Gdyni</name>
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  </location>
  <location>
    <facility>
      <name>Silmedic Sp. z o.o.</name>
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    <facility>
      <name>Zespol Opieki Zdrowotnej w Konskich</name>
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  <location>
    <facility>
      <name>Local Institution - 0182</name>
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  <location>
    <facility>
      <name>Local Institution - 0211</name>
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  <location>
    <facility>
      <name>Local Institution - 0222</name>
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  <location>
    <facility>
      <name>Centrum Medyczne ProMiMed</name>
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  <location>
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  <location>
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  <location>
    <facility>
      <name>Centrum Medyczne AMED Warszawa Targowek</name>
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  <location>
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  <location>
    <facility>
      <name>Local Institution - 0025</name>
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  </location>
  <location>
    <facility>
      <name>Neomed Research</name>
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  <location>
    <facility>
      <name>Centrul Medical Sana</name>
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  </location>
  <location>
    <facility>
      <name>Spitalul Sfanta Maria</name>
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        <city>Bucuresti</city>
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  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Dr. Ioan Cantacuzino</name>
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  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Cluj-Napoca</name>
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        <city>Cluj-Napoca</city>
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  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei</name>
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        <city>Galati</city>
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  </location>
  <location>
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      <name>Spitalul Judetean de Urgenta Valcea</name>
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  </location>
  <location>
    <facility>
      <name>CjSC</name>
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        <city>Ekaterinburg</city>
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  </location>
  <location>
    <facility>
      <name>Kemerovo State Medical University</name>
      <address>
        <city>Kemerovo</city>
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  </location>
  <location>
    <facility>
      <name>Medical Center Maksimum Zdorovia</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0210</name>
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        <city>Novosibirsk</city>
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  <location>
    <facility>
      <name>Local Institution - 0006</name>
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        <city>Orenburg</city>
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  </location>
  <location>
    <facility>
      <name>State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova</name>
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        <city>Petrozavodsk</city>
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  <location>
    <facility>
      <name>Local Institution - 0207</name>
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        <city>Saint - Petersburg</city>
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  <location>
    <facility>
      <name>Clinical Rheumatological Hospital Number 25</name>
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        <city>Saint Petersburg</city>
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  </location>
  <location>
    <facility>
      <name>Polyclinic of Private Security Personnel</name>
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        <city>Saint Petersburg</city>
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  <location>
    <facility>
      <name>Private Healthcare Institution Clinical Hospital</name>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0223</name>
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        <zip>197341</zip>
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  <location>
    <facility>
      <name>Tolyatti city clinical hospital ߵ</name>
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    <facility>
      <name>Biomed</name>
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        <zip>600005</zip>
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  <location>
    <facility>
      <name>Local Institution - 0208</name>
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    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2</name>
      <address>
        <city>Yaroslavl</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruna</name>
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        <city>A Coru</city>
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  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall dHebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga Hospital General</name>
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        <city>Malaga</city>
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        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Merida</name>
      <address>
        <city>Merida</city>
        <zip>06800</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitaria Parc Tauli</name>
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        <city>Sabadell</city>
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  </location>
  <location>
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      <name>Local Institution - 0228</name>
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        <city>Sevilla</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
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        <city>Changhua City</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0114</name>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
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        <city>Taipei City</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0088</name>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taipei</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
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        <city>Taipei</city>
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  </location>
  <location>
    <facility>
      <name>Local Institution</name>
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        <city>Taoyuan</city>
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  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>France</country>
    <country>Peru</country>
    <country>Ukraine</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>June 29, 2022</results_first_submitted>
  <results_first_submitted_qc>August 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2022</results_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deucravacitinib</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03252587/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03252587/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo PO BID</description>
        </group>
        <group group_id="P2">
          <title>BMS-986165 3 mg</title>
          <description>BMS-986165 3 mg PO BID</description>
        </group>
        <group group_id="P3">
          <title>BMS-986165 6 mg</title>
          <description>BMS-986165 6 mg PO BID</description>
        </group>
        <group group_id="P4">
          <title>BMS-986165 12 mg</title>
          <description>BMS-986165 12 mg PO QD</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="91"/>
                <participants group_id="P3" count="93"/>
                <participants group_id="P4" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="76"/>
                <participants group_id="P4" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" 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</title>
          <description>Placebo PO BID</description>
        </group>
        <group group_id="B2">
          <title>BMS-986165 3 mg</title>
          <description>BMS-986165 3 mg PO BID</description>
        </group>
        <group group_id="B3">
          <title>BMS-986165 6 mg</title>
          <description>BMS-986165 6 mg PO BID</description>
        </group>
        <group group_id="B4">
          <title>BMS-986165 12 mg</title>
          <description>BMS-986165 12 mg PO QD</description>
        </group>
        <group group_id="B5">
          <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="90"/>
            <count group_id="B2" value="91"/>
            <count group_id="B3" value="93"/>
            <count group_id="B4" value="89"/>
            <count group_id="B5" value="363"/>
          </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="40.1" spread="13.1"/>
                    <measurement group_id="B2" value="40.2" spread="11.9"/>
                    <measurement group_id="B3" value="40.9" spread="12.5"/>
                    <measurement group_id="B4" value="39.0" spread="10.6"/>
                    <measurement group_id="B5" value="40.1" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="81"/>
                    <measurement group_id="B5" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="29"/>
                  </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="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="57"/>
                    <measurement group_id="B5" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32</title>
        <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
        <time_frame>At week 32</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32</title>
          <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="46"/>
                    <measurement group_id="O4" value="40"/>
                  </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>
            <groups_desc>BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0210</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0781</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>2.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48</title>
        <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
        <time_frame>At week 48</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48</title>
          <description>SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="42"/>
                  </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>
            <groups_desc>BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.4</ci_lower_limit>
            <ci_upper_limit>4.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0434</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0439</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response</title>
        <description>BICLA responder is defined as a patient whose disease course fulfills all of the following:&#xD;
Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline&#xD;
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B&#xD;
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)&#xD;
No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment</description>
        <time_frame>At week 48</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response</title>
          <description>BICLA responder is defined as a patient whose disease course fulfills all of the following:&#xD;
Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline&#xD;
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B&#xD;
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)&#xD;
No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment</description>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="32"/>
                  </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>
            <groups_desc>BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.4</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0795</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0673</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)</title>
        <description>LLDAS is defined as follows:&#xD;
SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System&#xD;
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters&#xD;
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily&#xD;
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents</description>
        <time_frame>At Week 48</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)</title>
          <description>LLDAS is defined as follows:&#xD;
SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System&#xD;
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters&#xD;
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity&#xD;
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily&#xD;
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents</description>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="23"/>
                  </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>
            <groups_desc>BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.9</ci_lower_limit>
            <ci_upper_limit>8.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0371</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0168</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10</title>
        <description>Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia</description>
        <time_frame>At week 48</time_frame>
        <population>All Randomized Participants with Baseline CLASI Activity Score ≥ 10</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10</title>
          <description>Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia</description>
          <population>All Randomized Participants with Baseline CLASI Activity Score ≥ 10</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="18"/>
                  </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>
            <groups_desc>BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>10.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5</ci_lower_limit>
            <ci_upper_limit>43.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0058</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>22.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Regression, Logistic</method>
            <method_desc>1-sided</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>8.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>31.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the 40-Joint Count</title>
        <description>Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:&#xD;
Tender joint count (0 to 40)&#xD;
Swollen joint count (0 to 40)&#xD;
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.</description>
        <time_frame>Baseline and week 48</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the 40-Joint Count</title>
          <description>Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:&#xD;
Tender joint count (0 to 40)&#xD;
Swollen joint count (0 to 40)&#xD;
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.</description>
          <population>All Randomized Participants</population>
          <units>Units 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="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" spread="8.0"/>
                    <measurement group_id="O2" value="-12.2" spread="7.5"/>
                    <measurement group_id="O3" value="-11.7" spread="9.5"/>
                    <measurement group_id="O4" value="-12.3" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swollen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="6.9"/>
                    <measurement group_id="O2" value="-8.5" spread="4.2"/>
                    <measurement group_id="O3" value="-8.8" spread="7.2"/>
                    <measurement group_id="O4" value="-9.9" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tender + Swollen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="6.7"/>
                    <measurement group_id="O2" value="-8.2" spread="4.3"/>
                    <measurement group_id="O3" value="-8.5" spread="7.0"/>
                    <measurement group_id="O4" value="-9.7" spread="5.9"/>
                  </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>
            <groups_desc>Tender BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0131</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-2.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tender BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4156</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tender BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0151</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Swollen BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0029</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Swollen BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0516</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.46</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Swollen BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0298</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tender + Swollen BMS-986165 3 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.40</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tender + Swollen BMS-986165 6 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0343</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.40</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tender + Swollen BMS-986165 12 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0050</p_value>
            <method>Longitudinal Repeated Measures</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment</description>
        <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="85"/>
                    <measurement group_id="O3" value="81"/>
                    <measurement group_id="O4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities in Specific Liver Tests</title>
        <description>Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:&#xD;
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation &gt; 3× Upper Limit of Normal (ULN)&#xD;
Total bilirubin &gt; 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)&#xD;
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic</description>
        <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
        <population>All treated participants with evaluable measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities in Specific Liver Tests</title>
          <description>Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:&#xD;
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation &gt; 3× Upper Limit of Normal (ULN)&#xD;
Total bilirubin &gt; 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)&#xD;
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic</description>
          <population>All treated participants with evaluable measurements</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT or AST &gt; 3XULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="88"/>
                  </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="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST &gt; 5XULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin &gt; 2XULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="88"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST &gt; 3XULN and Total Bilirubin &gt; 2XULN on the same day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="88"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormalities in Vital Signs</title>
        <description>Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure</description>
        <time_frame>From first dose to 30 days post last dose (Up to 52 weeks)</time_frame>
        <population>All treated participants with evaluable measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormalities in Vital Signs</title>
          <description>Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure</description>
          <population>All treated participants with evaluable measurements</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="88"/>
                <count group_id="O3" value="91"/>
                <count group_id="O4" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </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="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </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="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </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="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="81"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="75"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="76"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="82"/>
                    <count group_id="O4" value="74"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="69"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </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="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="66"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </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="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </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="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="63"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="79"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="62"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Heart Rate: Value &gt; 100 and change from baseline &gt; 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Heart Rate: Value &lt; 55 and change from baseline &lt; -15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Systolic Blood Pressure: Value &gt; 140 and change from baseline &gt; 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Systolic Blood Pressure: Value &lt; 90 and change from baseline &lt; -20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Diastolic Blood Pressure: Value &gt; 90 and change from baseline &gt; 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Diastolic Blood Pressure: Value &lt; 55 and change from baseline &lt; -10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormalities in Electrocardiograms (ECGs)</title>
        <description>Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval</description>
        <time_frame>From baseline to up to week 48</time_frame>
        <population>All treated participants with evaluable measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormalities in Electrocardiograms (ECGs)</title>
          <description>Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval</description>
          <population>All treated participants with evaluable measurements</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="92"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: QTcF 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                  </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="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: QTcF &gt;= 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                  </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="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: PR Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: QRS Interval &gt;=200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: QTcF 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week4: QTcF &gt;= 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: PR Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: QRS Interval: &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="82"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: QTcF 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="80"/>
                  </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="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: QTcF &gt;=500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="80"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: PR Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 QRS Interval &gt;=200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="80"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: QTcF 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="73"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: QTcF &gt;= 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="73"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: PR Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: QRS Interval &gt;=200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="73"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: QTcF 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="60"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: QTcF &gt;=500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="60"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: PR Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: QRS Interval &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="60"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: QTcF: 450 to &lt; 480</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: QTcF 480 to &lt; 500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="58"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: QTcF &gt;=500</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="58"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: PR Interval: &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48: QRS Interval: &gt;= 200</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="72"/>
                    <count group_id="O4" value="58"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
        <time_frame>Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12</time_frame>
        <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
        <group_list>
          <group group_id="O1">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
          <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
          <units>NG/ML</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMS-986165</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.033" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 57.72</measurement>
                    <measurement group_id="O2" value="76.400" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 37.72</measurement>
                    <measurement group_id="O3" value="96.249" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 46.80</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.358" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 67.77</measurement>
                    <measurement group_id="O2" value="12.133" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 59.50</measurement>
                    <measurement group_id="O3" value="11.748" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 67.17</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)</title>
        <description>Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.</description>
        <time_frame>Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12</time_frame>
        <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
        <group_list>
          <group group_id="O1">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)</title>
          <description>Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.</description>
          <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMS-986165</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000" lower_limit="0.467" upper_limit="6.000"/>
                    <measurement group_id="O2" value="2.0000" lower_limit="0.500" upper_limit="7.533"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="0.500" upper_limit="5.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0000" lower_limit="0.550" upper_limit="7.500"/>
                    <measurement group_id="O2" value="4.0000" lower_limit="1.017" upper_limit="9.533"/>
                    <measurement group_id="O3" value="3.7330" lower_limit="0.500" upper_limit="6.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)</title>
        <description>Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
        <time_frame>Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48</time_frame>
        <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
        <group_list>
          <group group_id="O1">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)</title>
          <description>Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.</description>
          <population>All evaluable PK participants (all treated participants with available concentration-time data)</population>
          <units>NG/ML</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMS-986165 week 2</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="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3737" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 60.790</measurement>
                    <measurement group_id="O2" value="29.2909" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 47.588</measurement>
                    <measurement group_id="O3" value="30.8135" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 70.340</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6095" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 53.234</measurement>
                    <measurement group_id="O2" value="22.9170" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 51.043</measurement>
                    <measurement group_id="O3" value="20.1182" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 81.084</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0328" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 69.792</measurement>
                    <measurement group_id="O2" value="12.9587" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 64.799</measurement>
                    <measurement group_id="O3" value="26.7961" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 67.090</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7517" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 93.540</measurement>
                    <measurement group_id="O2" value="28.7751" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 47.282</measurement>
                    <measurement group_id="O3" value="22.1237" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 85.920</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2546" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 66.763</measurement>
                    <measurement group_id="O2" value="13.9273" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 67.922</measurement>
                    <measurement group_id="O3" value="21.8720" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 78.559</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5293" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 60.425</measurement>
                    <measurement group_id="O2" value="15.5285" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 61.704</measurement>
                    <measurement group_id="O3" value="24.5060" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 75.647</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMS-986165 week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8493" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 70.206</measurement>
                    <measurement group_id="O2" value="21.7890" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 53.718</measurement>
                    <measurement group_id="O3" value="15.9576" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 102.367</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 2</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="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2667" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 48.679</measurement>
                    <measurement group_id="O2" value="8.4841" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 54.717</measurement>
                    <measurement group_id="O3" value="8.7920" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 61.993</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0886" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 56.764</measurement>
                    <measurement group_id="O2" value="7.7803" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 53.563</measurement>
                    <measurement group_id="O3" value="7.2703" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 70.461</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1293" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 62.816</measurement>
                    <measurement group_id="O2" value="5.2290" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 71.924</measurement>
                    <measurement group_id="O3" value="8.1451" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 57.216</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7325" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 96.323</measurement>
                    <measurement group_id="O2" value="9.3281" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 54.823</measurement>
                    <measurement group_id="O3" value="7.4071" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 82.009</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3669" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 56.381</measurement>
                    <measurement group_id="O2" value="5.2229" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 71.104</measurement>
                    <measurement group_id="O3" value="6.6608" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 63.748</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9759" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 55.379</measurement>
                    <measurement group_id="O2" value="5.2925" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 63.200</measurement>
                    <measurement group_id="O3" value="6.8734" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 77.329</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite BMT-153261 week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8708" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 73.450</measurement>
                    <measurement group_id="O2" value="6.8838" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 58.302</measurement>
                    <measurement group_id="O3" value="5.8602" spread="NA">Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.&#xD;
%CV = 75.536</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels</title>
        <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 44</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels</title>
          <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IFN High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8130" spread="6.5323"/>
                    <measurement group_id="O2" value="-39.7478" spread="13.0087"/>
                    <measurement group_id="O3" value="-55.5691" spread="21.5313"/>
                    <measurement group_id="O4" value="-47.5561" spread="12.2125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFN Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7381" spread="8.8696"/>
                    <measurement group_id="O2" value="-18.0641" spread="27.0491"/>
                    <measurement group_id="O3" value="-36.4510" spread="22.4759"/>
                    <measurement group_id="O4" value="-41.7645" spread="26.1519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32</title>
        <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 32</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32</title>
          <description>Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IFN High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3993" spread="5.2234"/>
                    <measurement group_id="O2" value="-40.7944" spread="13.5929"/>
                    <measurement group_id="O3" value="-54.6988" spread="16.7734"/>
                    <measurement group_id="O4" value="-61.0515" spread="13.8367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFN Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6555" spread="9.2649"/>
                    <measurement group_id="O2" value="-27.4897" spread="20.0078"/>
                    <measurement group_id="O3" value="-42.8107" spread="19.7669"/>
                    <measurement group_id="O4" value="-42.9701" spread="23.8323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Complement Proteins C3 and C4 Levels</title>
        <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 52</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Complement Proteins C3 and C4 Levels</title>
          <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="12.225"/>
                    <measurement group_id="O2" value="5.33" spread="6.216"/>
                    <measurement group_id="O3" value="7.60" spread="5.315"/>
                    <measurement group_id="O4" value="14.74" spread="9.619"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.52" spread="88.618"/>
                    <measurement group_id="O2" value="3.57" spread="7.146"/>
                    <measurement group_id="O3" value="24.96" spread="20.508"/>
                    <measurement group_id="O4" value="20.43" spread="12.767"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Complement (C3, C4) Levels at Week 32</title>
        <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 32</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Complement (C3, C4) Levels at Week 32</title>
          <description>Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="3.038"/>
                    <measurement group_id="O2" value="5.78" spread="3.161"/>
                    <measurement group_id="O3" value="12.42" spread="2.748"/>
                    <measurement group_id="O4" value="10.84" spread="2.896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.27" spread="3.297"/>
                    <measurement group_id="O2" value="12.32" spread="4.455"/>
                    <measurement group_id="O3" value="16.71" spread="5.012"/>
                    <measurement group_id="O4" value="25.13" spread="6.988"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels</title>
        <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 52</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels</title>
          <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="276.26" spread="316.713"/>
                    <measurement group_id="O2" value="16.51" spread="28.265"/>
                    <measurement group_id="O3" value="-31.79" spread="10.209"/>
                    <measurement group_id="O4" value="-19.32" spread="8.722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32</title>
        <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
        <time_frame>From baseline to week 32</time_frame>
        <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32</title>
          <description>Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.</description>
          <population>All evaluable PD participants (all treated participants with at least one post-treatment measurement)</population>
          <units>Percent Change from Baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.36" spread="15.135"/>
                    <measurement group_id="O2" value="-15.24" spread="4.910"/>
                    <measurement group_id="O3" value="-11.31" spread="6.323"/>
                    <measurement group_id="O4" value="-24.17" spread="4.781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status</title>
        <description>Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
        <time_frame>At week 32</time_frame>
        <population>All randomized participants with SLE clinical response</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo PO BID</description>
          </group>
          <group group_id="O2">
            <title>BMS-986165 3 mg</title>
            <description>BMS-986165 3 mg PO BID</description>
          </group>
          <group group_id="O3">
            <title>BMS-986165 6 mg</title>
            <description>BMS-986165 6 mg PO BID</description>
          </group>
          <group group_id="O4">
            <title>BMS-986165 12 mg</title>
            <description>BMS-986165 12 mg PO QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status</title>
          <description>Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:&#xD;
A 4-point or greater reduction from baseline in SLEDAI-2K score&#xD;
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade&#xD;
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity</description>
          <population>All randomized participants with SLE clinical response</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IFN Low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFN High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo PO BID</description>
        </group>
        <group group_id="E2">
          <title>BMS-986165 3 mg</title>
          <description>BMS-986165 3 mg PO BID</description>
        </group>
        <group group_id="E3">
          <title>BMS-986165 6 mg</title>
          <description>BMS-986165 6 mg PO BID</description>
        </group>
        <group group_id="E4">
          <title>BMS-986165 12 mg</title>
          <description>BMS-986165 12 mg PO QD</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Scleritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pyelonephritis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the vagina</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Spinal cord disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous incomplete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="89"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</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/NCT03252587
org study id: IM011-021
secondary id: 2017-001203-79
nct id: NCT03252587
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will investigate BMS-986165 to assess its effects in participants with systemic
      lupus erythematosus (SLE).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
time frame: At week 32
description: SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
measure: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
time frame: At week 48
description: SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
measure: Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
time frame: At week 48
description: BICLA responder is defined as a patient whose disease course fulfills all of the following:
Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)
No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
measure: Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
time frame: At Week 48
description: LLDAS is defined as follows:
SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
measure: Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
time frame: At week 48
description: Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia
measure: Change From Baseline in the 40-Joint Count
time frame: Baseline and week 48
description: Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:
Tender joint count (0 to 40)
Swollen joint count (0 to 40)
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From first dose to 30 days post last dose (Up to 52 weeks)
description: Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
time frame: From first dose to 30 days post last dose (Up to 52 weeks)
description: Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN)
Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic
measure: Number of Participants With Abnormalities in Vital Signs
time frame: From first dose to 30 days post last dose (Up to 52 weeks)
description: Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
measure: Number of Participants With Abnormalities in Electrocardiograms (ECGs)
time frame: From baseline to up to week 48
description: Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
measure: BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
description: Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
measure: BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
description: Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
measure: BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
time frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
description: Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
measure: Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
time frame: From baseline to week 44
description: Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
measure: Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
time frame: From baseline to week 32
description: Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
measure: Percent Change From Baseline in Complement Proteins C3 and C4 Levels
time frame: From baseline to week 52
description: Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
measure: Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
time frame: From baseline to week 32
description: Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
measure: Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
time frame: From baseline to week 52
description: Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
measure: Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
time frame: From baseline to week 32
description: Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
measure: Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
time frame: At week 32
description: Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
arm group label: BMS-986165 Dose 1 oral administration
arm group type: Experimental
arm group label: BMS-986165 Dose 2 oral administration
arm group type: Experimental
arm group label: BMS-986165 Dose 3 oral administration
arm group type: Experimental
arm group label: Placebo oral administration
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BMS-986165
description: Specified dose on specified days
arm group label: BMS-986165 Dose 1 oral administration
arm group label: BMS-986165 Dose 2 oral administration
arm group label: BMS-986165 Dose 3 oral administration
intervention type: Other
intervention name: Placebo
description: Specified dose on specified days
arm group label: Placebo oral administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: Colombia
country: Germany
country: Hungary
country: Israel
country: Japan
country: Korea, Republic of
country: Mexico
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: United States
country: Bulgaria
country: France
country: Peru
country: Ukraine
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.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Deucravacitinib
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 