<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/NCT02966834</url>
  </required_header>
  <id_info>
    <org_study_id>201000</org_study_id>
    <secondary_id>2016-002416-41</secondary_id>
    <nct_id>NCT02966834</nct_id>
  </id_info>
  <brief_title>Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis</brief_title>
  <official_title>A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672&#xD;
      administration for the treatment of pruritus (itch) in participants with primary biliary&#xD;
      cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of&#xD;
      GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily).&#xD;
      Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study&#xD;
      has a prospectively defined adaptive design that will utilize interim data to further inform&#xD;
      and potentially optimize the doses under investigation. Hence, additional dose regimen may be&#xD;
      added during study. The total duration of a participant in the study will be up to 45 days of&#xD;
      screening and 24 weeks of study including follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2017</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 [V3]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (&gt;=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (&gt;)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serum ALP Concentrations Less Than (&lt;)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (&lt;=) ULN at Week 16</measure>
    <time_frame>At Week 16</time_frame>
    <description>Number of participants with ALP &lt; 1.67 times ULN and total bilirubin &lt;= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-SAEs and SAEs -Final Study Period</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-SAEs and SAEs - Follow-up Period</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Chemistry Data of Potential Clinical Importance</measure>
    <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
    <description>Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range [w/in] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100 percent (%). Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hematology Data of Potential Clinical Importance</measure>
    <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
    <description>Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100%. Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters</measure>
    <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
    <description>A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline and Week 20</time_frame>
    <description>SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate</measure>
    <time_frame>Baseline and Week 20</time_frame>
    <description>Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment</measure>
    <time_frame>Baseline and Week 20</time_frame>
    <description>GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Mean Worst Daily Itch Score of &lt;4 at Week 16</measure>
    <time_frame>At Week 16</time_frame>
    <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of &lt;4 at Week 16 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement of &gt;= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline</measure>
    <time_frame>Baseline and At Week 16</time_frame>
    <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</measure>
    <time_frame>Baseline and At Week 16</time_frame>
    <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responder Days With Worst Daily Itch Score of &lt;4</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of &lt;4 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responder Days With Improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responder Days With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Mean Daily Sleep Score at Week 16</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Mean Daily Fatigue Score at Week 16</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)</measure>
    <time_frame>Baseline and at Week 16</time_frame>
    <description>Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of GSK2330672 After Sparse Sampling</measure>
    <time_frame>At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)</time_frame>
    <description>Blood samples were collected for measurement of plasma GSK2330672 concentration.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Cholestasis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 20 mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive GSK2330672 and matching placebo to maintain blind</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 90 mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive GSK2330672 and matching placebo to maintain blind</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 180 mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive GSK2330672 and matching placebo to maintain blind</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 40 mg twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive GSK2330672 and matching placebo to maintain blind</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK2330672 90 mg twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive GSK2330672 and matching placebo to maintain blind</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>GSK2330672 matching placebo will be supplied as white film-coated tablets.</description>
    <arm_group_label>GSK2330672 180 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 20 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 40 mg twice daily</arm_group_label>
    <arm_group_label>GSK2330672 90 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 90 mg twice daily</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK2330672</intervention_name>
    <description>GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.</description>
    <arm_group_label>GSK2330672 180 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 20 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 40 mg twice daily</arm_group_label>
    <arm_group_label>GSK2330672 90 mg once daily</arm_group_label>
    <arm_group_label>GSK2330672 90 mg twice daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Participant must be 18 to 80 years of age inclusive, at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          -  Participants who have proven PBC, as demonstrated by having at least 2 of the&#xD;
             following: History of sustained increased ALP levels &gt;ULN first recognized at least 6&#xD;
             months prior to the Screening Visit (Sustained ALP elevations at the time of Screening&#xD;
             is not required, recognizing that the ALP may have decreased after institution of&#xD;
             ursodeoxycholic acid (UDCA) therapy as described in inclusion number 4). Documented&#xD;
             positive anti-mitochondrial antibody (AMA) titer (&gt;1:40 titer on immunofluorescence or&#xD;
             M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear&#xD;
             antibodies (antinuclear dot and/or nuclear rim positive). Liver biopsy (at any time in&#xD;
             the past) consistent with PBC.&#xD;
&#xD;
          -  Participants must rate their itch severity as being &gt;=4 on a 0 to 10 point scale for&#xD;
             the majority of time (at least half the days, as recalled by the participant) during&#xD;
             the 8 weeks prior to the Screening Visit. Periods of low itch or no itch are&#xD;
             acceptable as long as the worst daily itch score is &gt;=4 on the majority of days.&#xD;
&#xD;
          -  Participants who are currently taking UDCA should be on stable doses of UDCA for &gt;8&#xD;
             weeks at time of screening. Participants not taking UDCA due to intolerance may be&#xD;
             enrolled 8 weeks after their last dose of UDCA. No changes or discontinuation is&#xD;
             permitted until completion of the Main Study Period.&#xD;
&#xD;
          -  Male and/or female: Female participants- A female participant is eligible to&#xD;
             participate if she is not pregnant, not breastfeeding, and at least one of the&#xD;
             following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP&#xD;
             who agrees to follow the contraceptive guidance during the treatment period and until&#xD;
             at least 4 weeks after the last dose of study treatment.&#xD;
&#xD;
          -  Capable of giving signed informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the informed consent form (ICF) and in this&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Screening total bilirubin &gt;2x ULN. Total bilirubin &gt;2x ULN is acceptable if bilirubin&#xD;
             is fractionated and direct bilirubin &lt;35 percent (%).&#xD;
&#xD;
          -  Screening ALT or AST &gt;6x ULN.&#xD;
&#xD;
          -  Screening eGFR &lt;45 milliliter (mL)/minute/1.73 square meter (m^2) based on the&#xD;
             CKD-EPI.&#xD;
&#xD;
          -  History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy&#xD;
             or ascites).&#xD;
&#xD;
          -  Presence of actively replicating viral hepatitis due to hepatitis B or C virus (HBV,&#xD;
             HCV) infection, and/or confirmed hepatocellular carcinoma or biliary cancer. Other&#xD;
             hepatic conditions ( e.g., primary sclerosing cholangitis [PSC], alcoholic liver&#xD;
             disease, autoimmune hepatitis, non-alcoholic steatohepatitis [NASH] ) are permitted if&#xD;
             PBC is the dominant liver injury in the investigator's opinion.&#xD;
&#xD;
          -  Current diarrhea.&#xD;
&#xD;
          -  Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants&#xD;
             with history of cholecystectomy &gt;=3 months before screening may be eligible for&#xD;
             enrolment.&#xD;
&#xD;
          -  Any current medical condition (e.g. psychiatric disorder, senility or dementia), which&#xD;
             may affect the participant's ability to comply with the protocol specified procedures.&#xD;
&#xD;
          -  Initiation or increase in dose of colchicine, methotrexate, azathioprine, or systemic&#xD;
             corticosteroids in the 2 months prior to screening. If a change in dose in any of&#xD;
             these medications is anticipated during the course of the study, the participant&#xD;
             should be excluded.&#xD;
&#xD;
          -  Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3&#xD;
             months prior to screening. Participants may join the study on stable doses of these&#xD;
             medications, but no change or discontinuation is permitted until completion of the&#xD;
             Main Study Period.&#xD;
&#xD;
          -  Initiation or increase in dose of any of the following in the 8 weeks prior to&#xD;
             screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants&#xD;
             may join the study on stable or decreased doses of these medications, but no change in&#xD;
             dose is permitted until completion of the Main Study Period.&#xD;
&#xD;
          -  Bile acid binding resin use: a participant must discontinue use of cholestyramine,&#xD;
             colesevelam, colestipol or colestimide prior to the start of the Initial Study Period&#xD;
             (no later than Day-2). Note: these drugs may be administered after completion of the&#xD;
             Main Study Period, if clinically indicated.&#xD;
&#xD;
          -  Obeticholic acid use: a participant must discontinue use of obeticholic acid at least&#xD;
             8 weeks prior to the start of the Initial Study Period and may not restart until after&#xD;
             the end of the study.&#xD;
&#xD;
          -  Administration of any other Inhibitor of the Human Ileal Bile Acid Transporter (IBAT)&#xD;
             in the 3 months prior to screening.&#xD;
&#xD;
          -  Current enrolment or participation within the 8 weeks before start of the Initial&#xD;
             Study Period, in any other clinical study involving an investigational study&#xD;
             treatment.&#xD;
&#xD;
          -  QT interval corrected for heart rate QTc &gt;480 millisecond (msec).&#xD;
&#xD;
          -  History of sensitivity to the study treatment or components thereof or a history of&#xD;
             drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline&#xD;
             (GSK) Medical Monitor, contraindicates their participation in the study.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as an&#xD;
             average weekly intake of &gt;21 units for males or &gt;14 units for females. One unit is&#xD;
             equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass&#xD;
             (125 mL) of wine or 1 measure (25 mL) of spirits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manhasset</city>
        <state>New Jersey</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-8887</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>981104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Prahran</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lille cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paris cedex 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pessac cedex</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monza (MB)</city>
        <state>Lombardia</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>270-1694</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukui</city>
        <zip>918-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-8619</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>006-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagawa</city>
        <zip>760-8557</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagasaki</city>
        <zip>856-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>591-8025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-217</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-506</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Myslowice</city>
        <zip>41-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-332</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Basingstoke</city>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edgbaston</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G31 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Liverpool.</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newcastle-upon-Tyne</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sheffield</city>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <results_first_submitted>April 8, 2021</results_first_submitted>
  <results_first_submitted_qc>April 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 4, 2021</results_first_posted>
  <last_update_submitted>April 8, 2021</last_update_submitted>
  <last_update_submitted_qc>April 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>linerixibat</keyword>
  <keyword>PBC</keyword>
  <keyword>itch</keyword>
  <keyword>GSK2330672</keyword>
  <keyword>GLIMMER</keyword>
  <keyword>primary biliary cholangitis</keyword>
  <keyword>pruritus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Liver Cirrhosis, Biliary</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02966834/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02966834/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted across 66 centers in 10 countries. The 40 milligrams (mg) twice daily dose group was added and recruitment into the 20 mg twice daily dose group was discontinued following the pre-specified interim analysis.</recruitment_details>
      <pre_assignment_details>A total of 147 adult participants were randomized in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>GSK2330672 20 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="P3">
          <title>GSK2330672 90 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="P4">
          <title>GSK2330672 180 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="P5">
          <title>GSK2330672 40 mg BID</title>
          <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="P6">
          <title>GSK2330672 90 mg BID</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Main Study Period (Up to 12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="23"/>
                <participants group_id="P6" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued study treatment and entered follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Final Study Period (Up to 4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="21">One participant did not enter Final Study Period.</participants>
                <participants group_id="P6" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Follow-up (Up to 4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="23">4 participants discontinued study treatment in Main study period and directly entered follow-up.</participants>
                <participants group_id="P4" count="27">8 participants discontinued study treatment in Main Study period and directly entered follow-up.</participants>
                <participants group_id="P5" count="22">1 participant who completed main study period directly entered follow-up in this arm</participants>
                <participants group_id="P6" count="22">5 participants discontinued study treatment in Main study period and directly entered follow-up</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics is presented for Safety Population which consisted of all randomized participants who took at least one dose of randomized study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>GSK2330672 20 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="B3">
          <title>GSK2330672 90 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="B4">
          <title>GSK2330672 180 mg QD</title>
          <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="B5">
          <title>GSK2330672 40 mg BID</title>
          <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
        </group>
        <group group_id="B6">
          <title>GSK2330672 90 mg BID</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
        </group>
        <group group_id="B7">
          <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="36"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="27"/>
            <count group_id="B5" value="23"/>
            <count group_id="B6" value="22"/>
            <count group_id="B7" value="147"/>
          </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="54.4" spread="11.06"/>
                    <measurement group_id="B2" value="58.5" spread="7.35"/>
                    <measurement group_id="B3" value="52.5" spread="12.32"/>
                    <measurement group_id="B4" value="58.9" spread="11.10"/>
                    <measurement group_id="B5" value="55.6" spread="11.23"/>
                    <measurement group_id="B6" value="56.2" spread="11.32"/>
                    <measurement group_id="B7" value="55.8" spread="11.04"/>
                  </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="34"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian - Japanese Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White - White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score</title>
        <description>Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 [V3]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score</title>
          <description>Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 [V3]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.</description>
          <population>Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" lower_limit="-2.44" upper_limit="-1.01"/>
                    <measurement group_id="O2" value="-2.19" lower_limit="-3.26" upper_limit="-1.12"/>
                    <measurement group_id="O3" value="-2.60" lower_limit="-3.55" upper_limit="-1.65"/>
                    <measurement group_id="O4" value="-2.60" lower_limit="-3.51" upper_limit="-1.70"/>
                    <measurement group_id="O5" value="-2.86" lower_limit="-3.76" upper_limit="-1.95"/>
                    <measurement group_id="O6" value="-2.25" lower_limit="-3.19" upper_limit="-1.32"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.75</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.07</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.03</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.29</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale</title>
        <description>PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale</title>
          <description>PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-1.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-1.3" upper_limit="2.2"/>
                    <measurement group_id="O3" value="0.7" lower_limit="-0.8" upper_limit="2.3"/>
                    <measurement group_id="O4" value="-0.9" lower_limit="-2.4" upper_limit="0.6"/>
                    <measurement group_id="O5" value="0.3" lower_limit="-1.2" upper_limit="1.8"/>
                    <measurement group_id="O6" value="0.2" lower_limit="-1.4" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itch</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-3.3" upper_limit="-1.4"/>
                    <measurement group_id="O2" value="-1.9" lower_limit="-3.3" upper_limit="-0.4"/>
                    <measurement group_id="O3" value="-2.6" lower_limit="-3.9" upper_limit="-1.3"/>
                    <measurement group_id="O4" value="-2.7" lower_limit="-3.9" upper_limit="-1.4"/>
                    <measurement group_id="O5" value="-3.4" lower_limit="-4.6" upper_limit="-2.1"/>
                    <measurement group_id="O6" value="-2.7" lower_limit="-4.0" upper_limit="-1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-4.0" upper_limit="0.4"/>
                    <measurement group_id="O2" value="-2.4" lower_limit="-5.6" upper_limit="0.7"/>
                    <measurement group_id="O3" value="-1.1" lower_limit="-3.8" upper_limit="1.7"/>
                    <measurement group_id="O4" value="1.7" lower_limit="-1.0" upper_limit="4.5"/>
                    <measurement group_id="O5" value="-0.1" lower_limit="-2.8" upper_limit="2.6"/>
                    <measurement group_id="O6" value="-1.8" lower_limit="-4.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-1.7" upper_limit="1.1"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-2.4" upper_limit="1.8"/>
                    <measurement group_id="O3" value="-0.9" lower_limit="-2.7" upper_limit="0.9"/>
                    <measurement group_id="O4" value="-0.1" lower_limit="-1.9" upper_limit="1.6"/>
                    <measurement group_id="O5" value="0.1" lower_limit="-1.6" upper_limit="1.9"/>
                    <measurement group_id="O6" value="-0.1" lower_limit="-2.0" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-1.2" upper_limit="0.1"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-2.4" upper_limit="-0.4"/>
                    <measurement group_id="O3" value="-0.4" lower_limit="-1.3" upper_limit="0.5"/>
                    <measurement group_id="O4" value="-0.6" lower_limit="-1.5" upper_limit="0.3"/>
                    <measurement group_id="O5" value="-1.4" lower_limit="-2.2" upper_limit="-0.5"/>
                    <measurement group_id="O6" value="-0.6" lower_limit="-1.5" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-2.3" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-2.7" upper_limit="1.8"/>
                    <measurement group_id="O3" value="0.4" lower_limit="-1.5" upper_limit="2.4"/>
                    <measurement group_id="O4" value="-0.6" lower_limit="-2.5" upper_limit="1.3"/>
                    <measurement group_id="O5" value="-3.1" lower_limit="-5.1" upper_limit="-1.2"/>
                    <measurement group_id="O6" value="-1.0" lower_limit="-3.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</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>2.3</ci_upper_limit>
            <estimate_desc>Symptoms</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.5</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>2.5</ci_upper_limit>
            <estimate_desc>Symptoms</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
            <estimate_desc>Symptoms</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1</param_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>2.0</ci_upper_limit>
            <estimate_desc>Symptoms</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_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>1.9</ci_upper_limit>
            <estimate_desc>Symptoms</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
            <estimate_desc>Itch</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</param_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>1.3</ci_upper_limit>
            <estimate_desc>Itch</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>1.2</ci_upper_limit>
            <estimate_desc>Itch</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>Itch</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>1.3</ci_upper_limit>
            <estimate_desc>Itch</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.6</param_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>3.2</ci_upper_limit>
            <estimate_desc>Fatigue</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>4.2</ci_upper_limit>
            <estimate_desc>Fatigue</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
            <estimate_desc>Fatigue</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.7</param_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>5.1</ci_upper_limit>
            <estimate_desc>Fatigue</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
            <estimate_desc>Fatigue</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</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>2.6</ci_upper_limit>
            <estimate_desc>Cognitive</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
            <estimate_desc>Cognitive</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
            <estimate_desc>Cognitive</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.5</param_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>2.8</ci_upper_limit>
            <estimate_desc>Cognitive</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</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>2.5</ci_upper_limit>
            <estimate_desc>Cognitive</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
            <estimate_desc>Emotional</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</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>1.3</ci_upper_limit>
            <estimate_desc>Emotional</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
            <estimate_desc>Emotional</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.8</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>0.3</ci_upper_limit>
            <estimate_desc>Emotional</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
            <estimate_desc>Emotional</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.4</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
            <estimate_desc>Social</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>Social</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</param_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>2.7</ci_upper_limit>
            <estimate_desc>Social</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
            <estimate_desc>Social</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
            <estimate_desc>Social</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression</title>
        <description>Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (&gt;=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (&gt;)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations &gt;=1.67 times ULN and/or total bilirubin concentrations &gt;ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression</title>
          <description>Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (&gt;=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (&gt;)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
          <population>High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations &gt;=1.67 times ULN and/or total bilirubin concentrations &gt;ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed.</population>
          <units>International units per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" lower_limit="-29.3" upper_limit="127.6"/>
                    <measurement group_id="O2" value="-57.7" lower_limit="-179.6" upper_limit="64.3"/>
                    <measurement group_id="O3" value="-38.2" lower_limit="-117.0" upper_limit="40.5"/>
                    <measurement group_id="O4" value="49.6" lower_limit="-49.1" upper_limit="148.2"/>
                    <measurement group_id="O5" value="-29.2" lower_limit="-136.7" upper_limit="78.3"/>
                    <measurement group_id="O6" value="19.1" lower_limit="-97.7" upper_limit="136.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-106.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-251.7</ci_lower_limit>
            <ci_upper_limit>38.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-87.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-198.5</ci_lower_limit>
            <ci_upper_limit>23.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-125.6</ci_lower_limit>
            <ci_upper_limit>126.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-78.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-211.5</ci_lower_limit>
            <ci_upper_limit>54.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-30.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-170.7</ci_lower_limit>
            <ci_upper_limit>110.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serum ALP Concentrations Less Than (&lt;)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (&lt;=) ULN at Week 16</title>
        <description>Number of participants with ALP &lt; 1.67 times ULN and total bilirubin &lt;= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.</description>
        <time_frame>At Week 16</time_frame>
        <population>Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serum ALP Concentrations Less Than (&lt;)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (&lt;=) ULN at Week 16</title>
          <description>Number of participants with ALP &lt; 1.67 times ULN and total bilirubin &lt;= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.</description>
          <population>Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4).</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="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>International Units per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="-7.9" upper_limit="33.9"/>
                    <measurement group_id="O2" value="-8.4" lower_limit="-39.5" upper_limit="22.7"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-20.7" upper_limit="21.2"/>
                    <measurement group_id="O4" value="-2.0" lower_limit="-29.0" upper_limit="25.1"/>
                    <measurement group_id="O5" value="-13.5" lower_limit="-42.8" upper_limit="15.9"/>
                    <measurement group_id="O6" value="13.2" lower_limit="-17.4" upper_limit="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-21.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-58.4</ci_lower_limit>
            <ci_upper_limit>15.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-12.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.9</ci_lower_limit>
            <ci_upper_limit>16.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-15.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.9</ci_lower_limit>
            <ci_upper_limit>20.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-26.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-63.3</ci_lower_limit>
            <ci_upper_limit>10.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.7</ci_lower_limit>
            <ci_upper_limit>37.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>International Units per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.96" lower_limit="-4.55" upper_limit="32.46"/>
                    <measurement group_id="O2" value="-6.04" lower_limit="-34.20" upper_limit="22.12"/>
                    <measurement group_id="O3" value="-10.75" lower_limit="-28.90" upper_limit="7.40"/>
                    <measurement group_id="O4" value="-8.66" lower_limit="-32.24" upper_limit="14.93"/>
                    <measurement group_id="O5" value="-17.72" lower_limit="-42.77" upper_limit="7.34"/>
                    <measurement group_id="O6" value="8.16" lower_limit="-18.72" upper_limit="35.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-20.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-52.73</ci_lower_limit>
            <ci_upper_limit>12.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-24.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.80</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-22.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-53.39</ci_lower_limit>
            <ci_upper_limit>8.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-31.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-63.44</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-5.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.33</ci_lower_limit>
            <ci_upper_limit>26.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>International Units per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" lower_limit="-9.9" upper_limit="104.8"/>
                    <measurement group_id="O2" value="-58.5" lower_limit="-142.5" upper_limit="25.5"/>
                    <measurement group_id="O3" value="-18.0" lower_limit="-74.9" upper_limit="38.9"/>
                    <measurement group_id="O4" value="4.6" lower_limit="-66.5" upper_limit="75.8"/>
                    <measurement group_id="O5" value="-18.4" lower_limit="-93.6" upper_limit="56.8"/>
                    <measurement group_id="O6" value="-6.7" lower_limit="-89.1" upper_limit="75.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-106.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-205.1</ci_lower_limit>
            <ci_upper_limit>-6.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-65.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-148.5</ci_lower_limit>
            <ci_upper_limit>17.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-42.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-136.5</ci_lower_limit>
            <ci_upper_limit>50.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-65.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-161.2</ci_lower_limit>
            <ci_upper_limit>29.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-54.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-153.6</ci_lower_limit>
            <ci_upper_limit>45.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Micromoles per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.258" lower_limit="-2.068" upper_limit="4.583"/>
                    <measurement group_id="O2" value="-4.841" lower_limit="-9.693" upper_limit="0.011"/>
                    <measurement group_id="O3" value="-1.079" lower_limit="-4.345" upper_limit="2.187"/>
                    <measurement group_id="O4" value="-0.975" lower_limit="-5.150" upper_limit="3.201"/>
                    <measurement group_id="O5" value="-0.234" lower_limit="-4.914" upper_limit="4.446"/>
                    <measurement group_id="O6" value="6.494" lower_limit="1.622" upper_limit="11.365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-6.099</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.929</ci_lower_limit>
            <ci_upper_limit>-0.268</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.337</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.962</ci_lower_limit>
            <ci_upper_limit>2.289</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.232</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.679</ci_lower_limit>
            <ci_upper_limit>3.215</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.492</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.413</ci_lower_limit>
            <ci_upper_limit>4.430</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>5.236</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.591</ci_lower_limit>
            <ci_upper_limit>11.063</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Grams per Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-1.2" upper_limit="1.3"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-2.3" upper_limit="1.3"/>
                    <measurement group_id="O3" value="0.3" lower_limit="-1.0" upper_limit="1.6"/>
                    <measurement group_id="O4" value="0.8" lower_limit="-0.8" upper_limit="2.3"/>
                    <measurement group_id="O5" value="0.0" lower_limit="-1.7" upper_limit="1.7"/>
                    <measurement group_id="O6" value="0.7" lower_limit="-1.1" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3</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>2.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.7</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>2.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Ratio</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="-0.03" upper_limit="0.05"/>
                    <measurement group_id="O2" value="-0.01" lower_limit="-0.06" upper_limit="0.04"/>
                    <measurement group_id="O3" value="-0.03" lower_limit="-0.06" upper_limit="0.00"/>
                    <measurement group_id="O4" value="0.01" lower_limit="-0.04" upper_limit="0.05"/>
                    <measurement group_id="O5" value="-0.02" lower_limit="-0.07" upper_limit="0.02"/>
                    <measurement group_id="O6" value="-0.03" lower_limit="-0.08" upper_limit="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression</title>
        <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression</title>
          <description>Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
          <population>High Risk Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Seconds</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" lower_limit="-0.40" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.05" lower_limit="-0.33" upper_limit="0.44"/>
                    <measurement group_id="O3" value="-0.21" lower_limit="-0.47" upper_limit="0.05"/>
                    <measurement group_id="O4" value="0.02" lower_limit="-0.33" upper_limit="0.37"/>
                    <measurement group_id="O5" value="-0.18" lower_limit="-0.51" upper_limit="0.15"/>
                    <measurement group_id="O6" value="-0.17" lower_limit="-0.55" upper_limit="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>0.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Safety Population. It consisted of all randomized participants who received at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo -Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD - Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD - Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD - Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID - Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID - Main Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
          <population>Safety Population. It consisted of all randomized participants who received at least 1 dose of study intervention.</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="24"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-SAEs and SAEs -Final Study Period</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
        <time_frame>Up to 4 weeks</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID - Final Study Period</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-SAEs and SAEs -Final Study Period</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
          <population>Safety Population</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="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-SAEs and SAEs - Follow-up Period</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
        <time_frame>Up to 4 weeks</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Follow-up</title>
            <description>Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD - Follow-up</title>
            <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD - Follow-up</title>
            <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD - Follow-up</title>
            <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID - Follow-up</title>
            <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID - Follow-up</title>
            <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-SAEs and SAEs - Follow-up Period</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
          <population>Safety Population</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="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Chemistry Data of Potential Clinical Importance</title>
        <description>Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range [w/in] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100 percent (%). Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
        <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Chemistry Data of Potential Clinical Importance</title>
          <description>Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range [w/in] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100 percent (%). Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hematology Data of Potential Clinical Importance</title>
        <description>Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100%. Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
        <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hematology Data of Potential Clinical Importance</title>
          <description>Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the &quot;To w/in Range or No Change&quot; category. Participants were counted twice if the participant had values that changed &quot;To Low&quot; and &quot;To High&quot;, so the percentages may not add to 100%. Only &quot;To Low&quot; and/or &quot;To High&quot; categories with potential clinical importance data have been presented.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                  </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="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters</title>
        <description>A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
        <time_frame>At Weeks 8, 12, 16 and 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters</title>
          <description>A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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="3"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="21"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="20"/>
                  </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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and Week 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed .</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed .</population>
          <units>Millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="13.33"/>
                    <measurement group_id="O2" value="-2.1" spread="11.47"/>
                    <measurement group_id="O3" value="0.1" spread="12.78"/>
                    <measurement group_id="O4" value="0.7" spread="10.42"/>
                    <measurement group_id="O5" value="-0.3" spread="15.16"/>
                    <measurement group_id="O6" value="2.0" spread="15.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="8.99"/>
                    <measurement group_id="O2" value="0.3" spread="7.75"/>
                    <measurement group_id="O3" value="-0.3" spread="9.16"/>
                    <measurement group_id="O4" value="-0.7" spread="5.51"/>
                    <measurement group_id="O5" value="2.5" spread="8.64"/>
                    <measurement group_id="O6" value="2.3" spread="7.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate</title>
        <description>Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and Week 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate</title>
          <description>Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="7.19"/>
                    <measurement group_id="O2" value="-2.6" spread="10.35"/>
                    <measurement group_id="O3" value="1.2" spread="10.91"/>
                    <measurement group_id="O4" value="-0.2" spread="7.93"/>
                    <measurement group_id="O5" value="3.4" spread="8.92"/>
                    <measurement group_id="O6" value="0.5" spread="8.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment</title>
        <description>GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.</description>
        <time_frame>Baseline and Week 20</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed .</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment</title>
          <description>GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed .</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average Diarrhea Syndrome Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="1.343"/>
                    <measurement group_id="O2" value="0.15" spread="1.587"/>
                    <measurement group_id="O3" value="0.23" spread="1.180"/>
                    <measurement group_id="O4" value="-0.13" spread="0.637"/>
                    <measurement group_id="O5" value="-0.23" spread="1.729"/>
                    <measurement group_id="O6" value="0.22" spread="1.565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Indigestion Syndrome Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="1.138"/>
                    <measurement group_id="O2" value="0.09" spread="0.865"/>
                    <measurement group_id="O3" value="-0.03" spread="0.811"/>
                    <measurement group_id="O4" value="-0.14" spread="0.820"/>
                    <measurement group_id="O5" value="-0.31" spread="1.046"/>
                    <measurement group_id="O6" value="-0.54" spread="1.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Constipation Syndrome Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="1.045"/>
                    <measurement group_id="O2" value="-0.15" spread="0.989"/>
                    <measurement group_id="O3" value="0.32" spread="1.370"/>
                    <measurement group_id="O4" value="-0.02" spread="0.934"/>
                    <measurement group_id="O5" value="-0.32" spread="1.215"/>
                    <measurement group_id="O6" value="-0.37" spread="0.772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Abdominal Pain Syndrome Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="1.074"/>
                    <measurement group_id="O2" value="0.06" spread="0.712"/>
                    <measurement group_id="O3" value="-0.02" spread="1.000"/>
                    <measurement group_id="O4" value="-0.06" spread="0.629"/>
                    <measurement group_id="O5" value="-0.08" spread="0.885"/>
                    <measurement group_id="O6" value="-0.25" spread="0.904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Reflux Syndrome Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="1.208"/>
                    <measurement group_id="O2" value="-0.13" spread="0.619"/>
                    <measurement group_id="O3" value="-0.20" spread="1.332"/>
                    <measurement group_id="O4" value="-0.26" spread="0.664"/>
                    <measurement group_id="O5" value="-0.16" spread="0.762"/>
                    <measurement group_id="O6" value="-0.43" spread="0.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.830"/>
                    <measurement group_id="O2" value="0.02" spread="0.668"/>
                    <measurement group_id="O3" value="0.07" spread="0.802"/>
                    <measurement group_id="O4" value="-0.11" spread="0.433"/>
                    <measurement group_id="O5" value="-0.23" spread="0.690"/>
                    <measurement group_id="O6" value="-0.28" spread="0.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Mean Worst Daily Itch Score of &lt;4 at Week 16</title>
        <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of &lt;4 at Week 16 is presented.</description>
        <time_frame>At Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Mean Worst Daily Itch Score of &lt;4 at Week 16</title>
          <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of &lt;4 at Week 16 is presented.</description>
          <population>ITT Population</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>12.02</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>5.02</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>10.76</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>10.76</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>4.13</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement of &gt;= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
        <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
        <time_frame>Baseline and At Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement of &gt;= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
          <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
          <population>ITT Population</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>4.47</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>10.65</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>5.53</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>6.92</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>6.51</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
        <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
        <time_frame>Baseline and At Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
          <description>Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
          <population>ITT Population</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="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>3.04</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>6.91</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>3.08</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>6.42</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>5.99</ci_upper_limit>
            <estimate_desc>Analysis was performed using Logistic regression. No covariates were used.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responder Days With Worst Daily Itch Score of &lt;4</title>
        <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of &lt;4 is presented.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responder Days With Worst Daily Itch Score of &lt;4</title>
          <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of &lt;4 is presented.</description>
          <population>ITT Population</population>
          <units>Percentage of days</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.32" lower_limit="28.79" upper_limit="51.86"/>
                    <measurement group_id="O2" value="58.53" lower_limit="41.23" upper_limit="75.83"/>
                    <measurement group_id="O3" value="51.38" lower_limit="36.95" upper_limit="65.81"/>
                    <measurement group_id="O4" value="58.76" lower_limit="45.45" upper_limit="72.08"/>
                    <measurement group_id="O5" value="65.80" lower_limit="51.37" upper_limit="80.23"/>
                    <measurement group_id="O6" value="53.58" lower_limit="38.83" upper_limit="68.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>18.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.59</ci_lower_limit>
            <ci_upper_limit>39.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>11.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.42</ci_lower_limit>
            <ci_upper_limit>29.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>18.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>36.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>25.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.00</ci_lower_limit>
            <ci_upper_limit>43.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>13.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.47</ci_lower_limit>
            <ci_upper_limit>31.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responder Days With Improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
        <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responder Days With Improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
          <description>Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..</description>
          <population>ITT Population</population>
          <units>Percentage of days</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.46" lower_limit="27.30" upper_limit="49.61"/>
                    <measurement group_id="O2" value="53.44" lower_limit="36.71" upper_limit="70.18"/>
                    <measurement group_id="O3" value="45.43" lower_limit="31.47" upper_limit="59.39"/>
                    <measurement group_id="O4" value="50.23" lower_limit="37.35" upper_limit="63.12"/>
                    <measurement group_id="O5" value="60.29" lower_limit="46.33" upper_limit="74.25"/>
                    <measurement group_id="O6" value="60.03" lower_limit="45.76" upper_limit="74.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>14.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.13</ci_lower_limit>
            <ci_upper_limit>35.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.90</ci_lower_limit>
            <ci_upper_limit>24.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>11.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.27</ci_lower_limit>
            <ci_upper_limit>28.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>21.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.96</ci_lower_limit>
            <ci_upper_limit>39.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>21.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.46</ci_lower_limit>
            <ci_upper_limit>39.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responder Days With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
        <description>Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responder Days With Improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline</title>
          <description>Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of &gt;=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.</description>
          <population>ITT Population</population>
          <units>Percentage of days</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="23"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.56" lower_limit="19.96" upper_limit="43.16"/>
                    <measurement group_id="O2" value="37.71" lower_limit="20.31" upper_limit="55.11"/>
                    <measurement group_id="O3" value="38.82" lower_limit="24.31" upper_limit="53.33"/>
                    <measurement group_id="O4" value="40.69" lower_limit="27.29" upper_limit="54.08"/>
                    <measurement group_id="O5" value="51.49" lower_limit="36.98" upper_limit="66.00"/>
                    <measurement group_id="O6" value="58.60" lower_limit="43.76" upper_limit="73.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.76</ci_lower_limit>
            <ci_upper_limit>27.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.32</ci_lower_limit>
            <ci_upper_limit>25.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.59</ci_lower_limit>
            <ci_upper_limit>26.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>19.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.36</ci_lower_limit>
            <ci_upper_limit>38.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>27.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.20</ci_lower_limit>
            <ci_upper_limit>45.87</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Mean Daily Sleep Score at Week 16</title>
        <description>Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Mean Daily Sleep Score at Week 16</title>
          <description>Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" lower_limit="-2.06" upper_limit="-0.72"/>
                    <measurement group_id="O2" value="-1.66" lower_limit="-2.64" upper_limit="-0.67"/>
                    <measurement group_id="O3" value="-1.87" lower_limit="-2.75" upper_limit="-0.99"/>
                    <measurement group_id="O4" value="-1.85" lower_limit="-2.69" upper_limit="-1.01"/>
                    <measurement group_id="O5" value="-2.35" lower_limit="-3.19" upper_limit="-1.50"/>
                    <measurement group_id="O6" value="-1.69" lower_limit="-2.57" upper_limit="-0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.58</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.53</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.03</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Mean Daily Fatigue Score at Week 16</title>
        <description>Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Mean Daily Fatigue Score at Week 16</title>
          <description>Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.79" lower_limit="-1.39" upper_limit="-0.18"/>
                    <measurement group_id="O2" value="-1.18" lower_limit="-2.08" upper_limit="-0.27"/>
                    <measurement group_id="O3" value="-1.19" lower_limit="-2.00" upper_limit="-0.37"/>
                    <measurement group_id="O4" value="-1.04" lower_limit="-1.81" upper_limit="-0.28"/>
                    <measurement group_id="O5" value="-1.20" lower_limit="-1.97" upper_limit="-0.44"/>
                    <measurement group_id="O6" value="-1.07" lower_limit="-1.86" upper_limit="-0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.49</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.41</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.24</ci_lower_limit>
            <ci_upper_limit>0.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.39</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.28</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16</title>
        <description>The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16</title>
          <description>The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Duration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-1.1" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="-0.9" lower_limit="-1.3" upper_limit="-0.4"/>
                    <measurement group_id="O3" value="-0.4" lower_limit="-0.8" upper_limit="0.0"/>
                    <measurement group_id="O4" value="-1.2" lower_limit="-1.6" upper_limit="-0.8"/>
                    <measurement group_id="O5" value="-0.6" lower_limit="-1.0" upper_limit="-0.2"/>
                    <measurement group_id="O6" value="-0.7" lower_limit="-1.1" upper_limit="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-1.0" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="-0.9" lower_limit="-1.4" upper_limit="-0.5"/>
                    <measurement group_id="O3" value="-0.7" lower_limit="-1.1" upper_limit="-0.3"/>
                    <measurement group_id="O4" value="-0.7" lower_limit="-1.2" upper_limit="-0.3"/>
                    <measurement group_id="O5" value="-0.9" lower_limit="-1.3" upper_limit="-0.5"/>
                    <measurement group_id="O6" value="-0.8" lower_limit="-1.2" upper_limit="-0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-1.1" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-1.3" upper_limit="-0.1"/>
                    <measurement group_id="O3" value="-0.7" lower_limit="-1.2" upper_limit="-0.2"/>
                    <measurement group_id="O4" value="-0.9" lower_limit="-1.4" upper_limit="-0.4"/>
                    <measurement group_id="O5" value="-1.1" lower_limit="-1.6" upper_limit="-0.6"/>
                    <measurement group_id="O6" value="-0.7" lower_limit="-1.2" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.7" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-0.8" lower_limit="-1.4" upper_limit="-0.2"/>
                    <measurement group_id="O3" value="-0.5" lower_limit="-1.0" upper_limit="0.0"/>
                    <measurement group_id="O4" value="-0.7" lower_limit="-1.2" upper_limit="-0.2"/>
                    <measurement group_id="O5" value="-0.7" lower_limit="-1.2" upper_limit="-0.2"/>
                    <measurement group_id="O6" value="-0.7" lower_limit="-1.2" upper_limit="-0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distribution</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.7" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-1.2" upper_limit="-0.2"/>
                    <measurement group_id="O3" value="-0.7" lower_limit="-1.1" upper_limit="-0.3"/>
                    <measurement group_id="O4" value="-0.9" lower_limit="-1.3" upper_limit="-0.5"/>
                    <measurement group_id="O5" value="-0.7" lower_limit="-1.2" upper_limit="-0.3"/>
                    <measurement group_id="O6" value="-0.6" lower_limit="-1.0" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5-D Itch Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-4.2" upper_limit="-1.7"/>
                    <measurement group_id="O2" value="-4.0" lower_limit="-5.9" upper_limit="-2.0"/>
                    <measurement group_id="O3" value="-3.0" lower_limit="-4.7" upper_limit="-1.3"/>
                    <measurement group_id="O4" value="-4.4" lower_limit="-6.0" upper_limit="-2.7"/>
                    <measurement group_id="O5" value="-3.8" lower_limit="-5.4" upper_limit="-2.2"/>
                    <measurement group_id="O6" value="-3.5" lower_limit="-5.2" upper_limit="-1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>Duration</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
            <estimate_desc>Duration</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4</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>0.1</ci_upper_limit>
            <estimate_desc>Duration</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
            <estimate_desc>Duration</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
            <estimate_desc>Duration</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</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>0.3</ci_upper_limit>
            <estimate_desc>Degree</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>Degree</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>Degree</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Degree</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
            <estimate_desc>Degree</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
            <estimate_desc>Direction</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
            <estimate_desc>Direction</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</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>0.5</ci_upper_limit>
            <estimate_desc>Direction</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4</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>0.2</ci_upper_limit>
            <estimate_desc>Direction</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
            <estimate_desc>Direction</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4</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>0.3</ci_upper_limit>
            <estimate_desc>Disability</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</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>0.5</ci_upper_limit>
            <estimate_desc>Disability</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>0.3</ci_upper_limit>
            <estimate_desc>Disability</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>0.3</ci_upper_limit>
            <estimate_desc>Disability</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>0.3</ci_upper_limit>
            <estimate_desc>Disability</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>0.3</ci_upper_limit>
            <estimate_desc>Distribution</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.3</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>0.2</ci_upper_limit>
            <estimate_desc>Distribution</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5</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>0.0</ci_upper_limit>
            <estimate_desc>Distribution</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.3</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>0.2</ci_upper_limit>
            <estimate_desc>Distribution</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Distribution</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
            <estimate_desc>5-D Itch Total Score</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.1</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>2.1</ci_upper_limit>
            <estimate_desc>5-D Itch Total Score</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
            <estimate_desc>5-D Itch Total Score</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
            <estimate_desc>5-D Itch Total Score</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
            <estimate_desc>5-D Itch Total Score</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration</title>
        <description>Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration</title>
          <description>Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Micromoles per Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.274" spread="20.0163"/>
                    <measurement group_id="O2" value="-0.469" spread="6.5466"/>
                    <measurement group_id="O3" value="-3.878" spread="40.1857"/>
                    <measurement group_id="O4" value="-1.114" spread="6.9359"/>
                    <measurement group_id="O5" value="-2.133" spread="8.9308"/>
                    <measurement group_id="O6" value="7.379" spread="38.8282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)</title>
        <description>Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline and at Week 16</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)</title>
          <description>Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Micrograms per Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.746" spread="11.5644"/>
                    <measurement group_id="O2" value="10.703" spread="24.6045"/>
                    <measurement group_id="O3" value="11.452" spread="16.6371"/>
                    <measurement group_id="O4" value="29.488" spread="38.7584"/>
                    <measurement group_id="O5" value="58.674" spread="59.4833"/>
                    <measurement group_id="O6" value="40.629" spread="36.2769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of GSK2330672 After Sparse Sampling</title>
        <description>Blood samples were collected for measurement of plasma GSK2330672 concentration.</description>
        <time_frame>At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)</time_frame>
        <population>Pharmacokinetic (PK) Population consisted of any randomized participant who had at least one PK sample. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of GSK2330672 After Sparse Sampling</title>
          <description>Blood samples were collected for measurement of plasma GSK2330672 concentration.</description>
          <population>Pharmacokinetic (PK) Population consisted of any randomized participant who had at least one PK sample. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" spread="NA">Standard deviation could not be calculated as &gt;30% of samples were below the limit of quantification</measurement>
                    <measurement group_id="O2" value="5.00" spread="NA">Standard deviation could not be calculated as &gt;30% of samples were below the limit of quantification</measurement>
                    <measurement group_id="O3" value="32.71" spread="73.325"/>
                    <measurement group_id="O5" value="5.00" spread="NA">Standard deviation could not be calculated as &gt;30% of samples were below the limit of quantification</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358.04" spread="665.685"/>
                    <measurement group_id="O2" value="958.81" spread="1563.265"/>
                    <measurement group_id="O3" value="2327.58" spread="3737.965"/>
                    <measurement group_id="O4" value="453.45" spread="967.424"/>
                    <measurement group_id="O5" value="2908.06" spread="5106.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300.04" spread="356.268"/>
                    <measurement group_id="O2" value="820.87" spread="1143.023"/>
                    <measurement group_id="O3" value="2234.28" spread="3420.442"/>
                    <measurement group_id="O4" value="339.74" spread="357.914"/>
                    <measurement group_id="O5" value="1990.89" spread="4061.978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="447.88" spread="1160.518"/>
                    <measurement group_id="O2" value="1594.16" spread="3133.370"/>
                    <measurement group_id="O3" value="2060.51" spread="2888.033"/>
                    <measurement group_id="O4" value="419.47" spread="774.321"/>
                    <measurement group_id="O5" value="3531.36" spread="6296.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341.39" spread="638.359"/>
                    <measurement group_id="O2" value="1084.00" spread="1353.089"/>
                    <measurement group_id="O3" value="2569.00" spread="3727.883"/>
                    <measurement group_id="O4" value="303.83" spread="300.716"/>
                    <measurement group_id="O5" value="2197.16" spread="3604.704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="394.00" spread="162.151"/>
                    <measurement group_id="O2" value="864.26" spread="1045.467"/>
                    <measurement group_id="O3" value="3328.50" spread="3185.646"/>
                    <measurement group_id="O4" value="338.50" spread="236.881"/>
                    <measurement group_id="O5" value="703.60" spread="756.010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296.33" spread="118.154"/>
                    <measurement group_id="O2" value="578.00" spread="651.263"/>
                    <measurement group_id="O3" value="1940.50" spread="1128.203"/>
                    <measurement group_id="O4" value="364.50" spread="217.082"/>
                    <measurement group_id="O5" value="869.40" spread="1148.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Mean Change From Baseline in Monthly Itch Score</title>
        <description>Participants were required to score severity of their itching each morning and evening using a 0-10 NRS where 0(no itching) and 10(worst imaginable itching). The worst of these 2 scores was Worst Daily Itch Score. For each week, mean Worst Daily Itch Score was calculated to form Mean Worst Daily Itch Score. The Monthly Itch Score was defined as worst weekly score (e.g., Mean Worst Daily Itch Score) for that month. The monthly itch score ranges from 0 to 10, higher score indicates worst imaginable itching. Baseline is average of scores in the 7 days prior to Week 4 (Visit 3 [V3]). Change from Baseline was calculated as post-Baseline value minus Baseline value. Mean change from Baseline in monthly itch score over 12 week treatment period is presented. Analysis was performed on change in Monthly Itch Scores over 12 week treatment period using Mixed model repeated measures (MMRM) with Baseline itch, treatment group, visit and a treatment group*visit interaction as covariates in the model.</description>
        <time_frame>Baseline and up to Week 12</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Monthly Itch Score</title>
          <description>Participants were required to score severity of their itching each morning and evening using a 0-10 NRS where 0(no itching) and 10(worst imaginable itching). The worst of these 2 scores was Worst Daily Itch Score. For each week, mean Worst Daily Itch Score was calculated to form Mean Worst Daily Itch Score. The Monthly Itch Score was defined as worst weekly score (e.g., Mean Worst Daily Itch Score) for that month. The monthly itch score ranges from 0 to 10, higher score indicates worst imaginable itching. Baseline is average of scores in the 7 days prior to Week 4 (Visit 3 [V3]). Change from Baseline was calculated as post-Baseline value minus Baseline value. Mean change from Baseline in monthly itch score over 12 week treatment period is presented. Analysis was performed on change in Monthly Itch Scores over 12 week treatment period using Mixed model repeated measures (MMRM) with Baseline itch, treatment group, visit and a treatment group*visit interaction as covariates in the model.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" lower_limit="-1.01" upper_limit="0.08"/>
                    <measurement group_id="O2" value="-1.17" lower_limit="-1.99" upper_limit="-0.35"/>
                    <measurement group_id="O3" value="-1.08" lower_limit="-1.77" upper_limit="-0.39"/>
                    <measurement group_id="O4" value="-1.36" lower_limit="-2.03" upper_limit="-0.69"/>
                    <measurement group_id="O5" value="-1.63" lower_limit="-2.32" upper_limit="-0.93"/>
                    <measurement group_id="O6" value="-1.41" lower_limit="-2.13" upper_limit="-0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.69</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.49</ci_lower_limit>
            <ci_upper_limit>0.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>-0.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.05</ci_lower_limit>
            <ci_upper_limit>-0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.85</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Ratio to Baseline in Total Serum Bile Acid Concentration</title>
        <description>Blood samples were collected for evaluation of total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in total serum bile acid concentration on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline total serum bile acid, visit, treatment group, a log-transformed Baseline total serum bile acid*visit interaction, and a treatment group*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.</description>
        <time_frame>Baseline and up to Week 12</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio to Baseline in Total Serum Bile Acid Concentration</title>
          <description>Blood samples were collected for evaluation of total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in total serum bile acid concentration on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline total serum bile acid, visit, treatment group, a log-transformed Baseline total serum bile acid*visit interaction, and a treatment group*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Ratio</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" lower_limit="0.801" upper_limit="1.273"/>
                    <measurement group_id="O2" value="0.977" lower_limit="0.688" upper_limit="1.386"/>
                    <measurement group_id="O3" value="1.182" lower_limit="0.874" upper_limit="1.6"/>
                    <measurement group_id="O4" value="0.918" lower_limit="0.687" upper_limit="1.226"/>
                    <measurement group_id="O5" value="0.697" lower_limit="0.519" upper_limit="0.938"/>
                    <measurement group_id="O6" value="0.833" lower_limit="0.616" upper_limit="1.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Square (LS) mean ratio</param_type>
            <param_value>0.967</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.635</ci_lower_limit>
            <ci_upper_limit>1.471</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>1.17</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>1.712</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>0.909</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.627</ci_lower_limit>
            <ci_upper_limit>1.316</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.474</ci_lower_limit>
            <ci_upper_limit>1.005</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>0.825</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.564</ci_lower_limit>
            <ci_upper_limit>1.207</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration</title>
        <description>Blood samples were collected for evaluation of C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in C4 on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline C4, visit, treatment group, a log-transformed Baseline C4*visit interaction, and a treatment group*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.</description>
        <time_frame>Baseline and up to Week 12</time_frame>
        <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GSK2330672 20 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O3">
            <title>GSK2330672 90 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route</description>
          </group>
          <group group_id="O4">
            <title>GSK2330672 180 mg QD</title>
            <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O5">
            <title>GSK2330672 40 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.</description>
          </group>
          <group group_id="O6">
            <title>GSK2330672 90 mg BID</title>
            <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration</title>
          <description>Blood samples were collected for evaluation of C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in C4 on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline C4, visit, treatment group, a log-transformed Baseline C4*visit interaction, and a treatment group*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.</description>
          <population>ITT Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Ratio</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.158" lower_limit="0.937" upper_limit="1.431"/>
                    <measurement group_id="O2" value="1.579" lower_limit="1.151" upper_limit="2.166"/>
                    <measurement group_id="O3" value="2.374" lower_limit="1.812" upper_limit="3.109"/>
                    <measurement group_id="O4" value="2.846" lower_limit="2.192" upper_limit="3.694"/>
                    <measurement group_id="O5" value="3.622" lower_limit="2.753" upper_limit="4.764"/>
                    <measurement group_id="O6" value="3.127" lower_limit="2.385" upper_limit="4.101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>1.363</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.932</ci_lower_limit>
            <ci_upper_limit>1.995</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>2.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.456</ci_lower_limit>
            <ci_upper_limit>2.887</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>2.457</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.758</ci_lower_limit>
            <ci_upper_limit>3.436</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>3.128</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.206</ci_lower_limit>
            <ci_upper_limit>4.435</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS mean ratio</param_type>
            <param_value>2.701</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.915</ci_lower_limit>
            <ci_upper_limit>3.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period.</time_frame>
      <desc>Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.</description>
        </group>
        <group group_id="E2">
          <title>GSK2330672 20 mg QD - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.</description>
        </group>
        <group group_id="E3">
          <title>GSK2330672 90 mg QD - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.</description>
        </group>
        <group group_id="E4">
          <title>GSK2330672 180 mg QD - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.</description>
        </group>
        <group group_id="E5">
          <title>GSK2330672 40 mg BID - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.</description>
        </group>
        <group group_id="E6">
          <title>GSK2330672 90 mg BID - Main Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.</description>
        </group>
        <group group_id="E7">
          <title>Placebo - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.</description>
        </group>
        <group group_id="E8">
          <title>GSK2330672 20 mg QD - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.</description>
        </group>
        <group group_id="E9">
          <title>GSK2330672 90 mg QD - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.</description>
        </group>
        <group group_id="E10">
          <title>GSK2330672 180 mg QD - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.</description>
        </group>
        <group group_id="E11">
          <title>GSK2330672 40 mg BID - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.</description>
        </group>
        <group group_id="E12">
          <title>GSK2330672 90 mg BID - Final Study Period</title>
          <description>Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.</description>
        </group>
        <group group_id="E13">
          <title>Placebo - Follow-up</title>
          <description>Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
        <group group_id="E14">
          <title>GSK2330672 20 mg QD - Follow-up</title>
          <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
        <group group_id="E15">
          <title>GSK2330672 90 mg QD - Follow-up</title>
          <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
        <group group_id="E16">
          <title>GSK2330672 180 mg QD - Follow-up</title>
          <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
        <group group_id="E17">
          <title>GSK2330672 40 mg BID - Follow-up</title>
          <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
        <group group_id="E18">
          <title>GSK2330672 90 mg BID - Follow-up</title>
          <description>Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="23"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="19"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E3" events="20" subjects_affected="15" subjects_at_risk="23"/>
                <counts group_id="E4" events="22" subjects_affected="18" subjects_at_risk="27"/>
                <counts group_id="E5" events="14" subjects_affected="12" subjects_at_risk="23"/>
                <counts group_id="E6" events="15" subjects_affected="15" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone fissure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Vitamin A deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT02966834
org study id: 201000
secondary id: 2016-002416-41
nct id: NCT02966834
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672
      administration for the treatment of pruritus (itch) in participants with primary biliary
      cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of
      GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily).
      Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study
      has a prospectively defined adaptive design that will utilize interim data to further inform
      and potentially optimize the doses under investigation. Hence, additional dose regimen may be
      added during study. The total duration of a participant in the study will be up to 45 days of
      screening and 24 weeks of study including follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score
time frame: Baseline and Week 16
description: Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 [V3]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.
measure: Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale
time frame: Baseline and at Week 16
description: PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (>=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (>)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
measure: Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16
time frame: At Week 16
description: Number of participants with ALP < 1.67 times ULN and total bilirubin <= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.
measure: Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
measure: Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression
time frame: Baseline and at Week 16
description: Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
measure: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period
time frame: Up to 12 weeks
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
measure: Number of Participants With Non-SAEs and SAEs -Final Study Period
time frame: Up to 4 weeks
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
measure: Number of Participants With Non-SAEs and SAEs - Follow-up Period
time frame: Up to 4 weeks
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
measure: Number of Participants With Clinical Chemistry Data of Potential Clinical Importance
time frame: At Weeks 8, 12, 16 and 20
description: Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range [w/in] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], high to high), or whose value became within range, were recorded in the "To w/in Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100 percent (%). Only "To Low" and/or "To High" categories with potential clinical importance data have been presented.
measure: Number of Participants With Hematology Data of Potential Clinical Importance
time frame: At Weeks 8, 12, 16 and 20
description: Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the "To w/in Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Only "To Low" and/or "To High" categories with potential clinical importance data have been presented.
measure: Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters
time frame: At Weeks 8, 12, 16 and 20
description: A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline and Week 20
description: SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Change From Baseline in Pulse Rate
time frame: Baseline and Week 20
description: Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment
time frame: Baseline and Week 20
description: GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.
measure: Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16
time frame: At Week 16
description: Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of <4 at Week 16 is presented.
measure: Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline
time frame: Baseline and At Week 16
description: Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
measure: Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline
time frame: Baseline and At Week 16
description: Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
measure: Percentage of Responder Days With Worst Daily Itch Score of <4
time frame: Up to Week 16
description: Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of <4 is presented.
measure: Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline
time frame: Baseline and at Week 16
description: Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..
measure: Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline
time frame: Baseline and at Week 16
description: Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
measure: Change From Baseline in the Mean Daily Sleep Score at Week 16
time frame: Baseline and at Week 16
description: Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
measure: Change From Baseline in the Mean Daily Fatigue Score at Week 16
time frame: Baseline and at Week 16
description: Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
measure: Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16
time frame: Baseline and at Week 16
description: The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.
measure: Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration
time frame: Baseline and at Week 16
description: Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)
time frame: Baseline and at Week 16
description: Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Plasma Concentration of GSK2330672 After Sparse Sampling
time frame: At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)
description: Blood samples were collected for measurement of plasma GSK2330672 concentration.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive matching placebo
arm group label: GSK2330672 20 mg once daily
arm group type: Experimental
description: Participants will receive GSK2330672 and matching placebo to maintain blind
arm group label: GSK2330672 90 mg once daily
arm group type: Experimental
description: Participants will receive GSK2330672 and matching placebo to maintain blind
arm group label: GSK2330672 180 mg once daily
arm group type: Experimental
description: Participants will receive GSK2330672 and matching placebo to maintain blind
arm group label: GSK2330672 40 mg twice daily
arm group type: Experimental
description: Participants will receive GSK2330672 and matching placebo to maintain blind
arm group label: GSK2330672 90 mg twice daily
arm group type: Experimental
description: Participants will receive GSK2330672 and matching placebo to maintain blind
intervention type: Drug
intervention name: Placebo
description: GSK2330672 matching placebo will be supplied as white film-coated tablets.
arm group label: GSK2330672 180 mg once daily
arm group label: GSK2330672 20 mg once daily
arm group label: GSK2330672 40 mg twice daily
arm group label: GSK2330672 90 mg once daily
arm group label: GSK2330672 90 mg twice daily
arm group label: Placebo
intervention type: Drug
intervention name: GSK2330672
description: GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.
arm group label: GSK2330672 180 mg once daily
arm group label: GSK2330672 20 mg once daily
arm group label: GSK2330672 40 mg twice daily
arm group label: GSK2330672 90 mg once daily
arm group label: GSK2330672 90 mg twice daily
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: Japan
country: Poland
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Cholestasis
mesh term: Liver Cirrhosis, Biliary
mesh term: Pruritus
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 