<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/NCT03041025</url>
  </required_header>
  <id_info>
    <org_study_id>201247</org_study_id>
    <secondary_id>2016-003417-95</secondary_id>
    <nct_id>NCT03041025</nct_id>
  </id_info>
  <brief_title>Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic Sclerosis</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>
      GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis&#xD;
      (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no&#xD;
      approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811&#xD;
      has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with&#xD;
      fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,&#xD;
      randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be&#xD;
      the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and&#xD;
      pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female&#xD;
      participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a&#xD;
      disease duration of &lt;= 60 months will be enrolled. Approximately 24 to 40 participants will&#xD;
      be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted&#xD;
      to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is&#xD;
      planned to consist of at least 4 participants, randomized such that 3 participants will&#xD;
      receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to&#xD;
      consist of at least 20 participants, randomized such that participants will receive&#xD;
      GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to&#xD;
      34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and&#xD;
      follow-up period of 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Day 197, but protocol allowed for additional events to be collected; up to Day 603 post first dose</time_frame>
    <description>An adverse event (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. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameter: Hematocrit</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH)</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV)</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW)</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Reticulocyte Production Index</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent [%]) multiply by (x) (hematocrit [%] divided by [/] 45) x 1/ reticulocyte maturation time'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Hematology Parameter: Reticulocytes</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline</measure>
    <time_frame>Up to Day 197</time_frame>
    <description>Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: &lt;30 grams per liter (g/L) (albumin), high: &gt;44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: &lt;3 or high: &gt;9 mmol/L (glucose), low: &lt;3 or high: &gt;5.5 mmol/L (potassium), and low: &lt;130 or high: &gt;150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was 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 within Range or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add up to 100%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameter: Total Protein</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH)</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides</measure>
    <time_frame>Baseline (Day 1: Pre-dose) and Day 85</time_frame>
    <description>Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick</measure>
    <time_frame>Up to Day 197</time_frame>
    <description>Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria</measure>
    <time_frame>Baseline (Day 1: Pre-dose) and up to Day 197</time_frame>
    <description>Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of &gt;=40 millimeter of mercury [mmHg]), DBP (increase or decrease from Baseline of &gt;=20 mmHg), and HR (increase or decrease from Baseline of &gt;=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Body Temperature</measure>
    <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
    <description>Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings</measure>
    <time_frame>Up to Day 57</time_frame>
    <description>Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of GSK2330811</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL/F) of GSK2330811</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vss/F) of GSK2330811</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Level of Total Oncostatin M (OSM)</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Level of Free OSM</measure>
    <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
    <description>Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-GSK2330811 Antibodies</measure>
    <time_frame>Days 1, 15, 57, 85 and 197</time_frame>
    <description>Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Scleroderma, Systemic</condition>
  <arm_group>
    <arm_group_label>Cohort 1: GSK2330811 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During Cohort 1, participants will receive a single dose of GSK2330811 100 mg by SC injection via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: GSK2330811 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During Cohort 2, participants will receive a single dose of GSK2330811 300 mg by SC injection (3 vials of 1 mL each of GSK2330811 100 mg) via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During Cohort 1, participants will receive a single dose of placebo by SC injection via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During Cohort 2, participants will receive a single dose of placebo by SC injection (3 vials of 1 mL each) via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK2330811</intervention_name>
    <description>GSK2330811 will be provided in vials and packed in 1 vial per carton. Each vial will contain 1.2 mL fill with 1 mL extractable volume at 100 mg/mL.</description>
    <arm_group_label>Cohort 1: GSK2330811 100 mg</arm_group_label>
    <arm_group_label>Cohort 2: GSK2330811 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline (0.9 percent weight per volume sodium chloride).</description>
    <arm_group_label>Cohort 1: Placebo</arm_group_label>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants of 18 years or over, at the time of signing the informed consent.&#xD;
&#xD;
          -  Documented diagnosis of systemic sclerosis with diffuse cutaneous involvement.&#xD;
&#xD;
          -  Modified rodnan skin score (mRSS) &gt;=10 and &lt;=35 at screening.&#xD;
&#xD;
          -  In all cases, a disease duration of &lt;=60 months at screening, defined as time from&#xD;
             onset of the first non-Raynaud's phenomenon manifestation.&#xD;
&#xD;
          -  Active disease defined by at least one of the following criteria at screening:&#xD;
&#xD;
               -  C-Reactive Protein (CRP) &gt;=6 mg/liter (L) (0.6 mg/deciliter [dL]), that in the&#xD;
                  opinion of the investigator is due to SSc.&#xD;
&#xD;
               -  Disease duration &lt;=18 months at screening, defined as time from the first&#xD;
                  non-Raynaud's phenomenon manifestation.&#xD;
&#xD;
               -  Increase of &gt;=3 mRSS units, compared with an assessment performed within the&#xD;
                  previous 6 months.&#xD;
&#xD;
               -  Involvement of one new body area and an increase of &gt;=2 mRSS units compared with&#xD;
                  an assessment performed within the previous 6 months.&#xD;
&#xD;
               -  Involvement of two new body areas within the previous 6 months.&#xD;
&#xD;
          -  An area of uninvolved or mildly thickened skin that in the opinion of the investigator&#xD;
             would allow subcutaneous injection either at abdomen, front or middle region of the&#xD;
             thigh or at outer area of the upper arm.&#xD;
&#xD;
          -  An area of involved skin (mRSS &gt;=1) on the forearm suitable for repeated skin biopsies&#xD;
             to be collected.&#xD;
&#xD;
          -  Participants who are taking mycophenolate mofetil (&lt;=3,000 mg/day) or equivalent&#xD;
             mycophenolate sodium (&lt;=2160 mg/day) are permitted in the study if the participant has&#xD;
             been on a stable dose for &gt;=3 months at the first dosing day (Day 1) and participant&#xD;
             and investigator are willing to continue this dose until at least completion of the&#xD;
             Day 85 (Week 12) visit. If mycophenolate was recently ceased, there must be &gt;=3 months&#xD;
             between the date mycophenolate was ceased and the first dosing day (Day 1).&#xD;
&#xD;
          -  Participants who are taking oral corticosteroids (&lt;=10 mg/day of prednisone or&#xD;
             equivalent) are permitted in the study if the participant has been receiving a dose no&#xD;
             greater than 10 mg/day for at least 4 weeks at the first dosing day (Day 1) and the&#xD;
             investigator does not anticipate increasing the dose above 10 mg/day during the study.&#xD;
&#xD;
          -  Participants who are taking phosphodiesterase 5 (PDE5) inhibitors and endothelin&#xD;
             receptor antagonists (including bosentan) are permitted in the study if the&#xD;
             participant has been on a stable dose for at least 4 weeks for PDE5 inhibitors and for&#xD;
             at least 3 months for endothelin antagonists at the first dosing day (Day 1) and&#xD;
             participant and investigator are willing to continue this dose until at least&#xD;
             completion of the Day 85 (Week 12) visit.&#xD;
&#xD;
          -  Participants who are taking non-immunosuppressive medications are permitted in the&#xD;
             study (e.g. hydroxychloroquine, angiotensin converting enzyme (ACE)&#xD;
             inhibitors/angiotensin II receptor (AR) blockers, calcium-channel blockers and&#xD;
             proton-pump inhibitors). However no new long-term medications and no dose-changes to&#xD;
             existing long term medications are permitted during the two weeks prior to the first&#xD;
             dosing day (Day 1).&#xD;
&#xD;
          -  Male participants must agree to use contraception during the dosing period and for at&#xD;
             least 126 days (18 weeks) after the last dose of study treatment and refrain from&#xD;
             donating sperm during this period.&#xD;
&#xD;
          -  A female participant is eligible to participate if she is not pregnant, not&#xD;
             breastfeeding, and either she is not a woman of childbearing potential (WOCBP) or she&#xD;
             is a WOCBP who agrees to use contraceptives from 28 days prior to first dosing day&#xD;
             (Day 1), during the dosing period and for at least 126 days (18 weeks) after the last&#xD;
             dose of study treatment.&#xD;
&#xD;
          -  Capable of giving signed informed consent which includes compliance with the&#xD;
             requirements and restrictions for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants classified to the limited cutaneous SSc subset, as determined by the&#xD;
             investigator.&#xD;
&#xD;
          -  Rheumatic autoimmune disease other than dcSSc including but not limited to rheumatoid&#xD;
             arthritis, systemic lupus erythematosus, mixed connective tissue disorder,&#xD;
             polymyositis, dermatomyositis, systemic vasculitis and primary Sjogren's syndrome, as&#xD;
             determined by the investigator.&#xD;
&#xD;
          -  Forced vital capacity (FVC) &lt;=50 percentage of predicted, or a diffusing capacity of&#xD;
             the lung for carbon dioxide (DLCO) (corrected for hemoglobin) &lt;=40 percentage of&#xD;
             predicted at screening.&#xD;
&#xD;
          -  Pulmonary arterial hypertension, as determined by the investigator.&#xD;
&#xD;
          -  Clinically significant inflammatory myositis (related to SSc), as determined by the&#xD;
             investigator.&#xD;
&#xD;
          -  SSc renal crisis within 6 months of the first day of dosing (Day 1).&#xD;
&#xD;
          -  History of clinically significant or uncontrolled cardiac, endocrinologic,&#xD;
             hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,&#xD;
             dermatologic, psychiatric, renal, and/or other major disease at screening not related&#xD;
             to SSc and that in the opinion of the investigator would prevent participation in the&#xD;
             study.&#xD;
&#xD;
          -  Known bleeding or coagulation disorder.&#xD;
&#xD;
          -  Major surgery (including joint surgery) within 3 months prior to screening, or planned&#xD;
             during the duration of the study.&#xD;
&#xD;
          -  Clinically significant multiple or severe drug allergies (including to humanized&#xD;
             monoclonal antibodies), intolerance to topical corticosteroids, or severe&#xD;
             post-treatment hypersensitivity reactions (including, but not limited to, erythema&#xD;
             multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal&#xD;
             necrolysis, and exfoliative dermatitis).&#xD;
&#xD;
          -  An active infection, or a history of infections as follows:&#xD;
&#xD;
               -  History of opportunistic infections that have not resolved by 6 months prior to&#xD;
                  the first day of dosing (Day1) or recurrent infection as determined by the&#xD;
                  investigator. This does not include infections that may occur in immunocompetent&#xD;
                  individuals, such as fungal nail infections or vaginal candidiasis, unless it is&#xD;
                  of an unusual severity or frequency.&#xD;
&#xD;
               -  A serious infection requiring treatment with intravenous antibiotics and/or&#xD;
                  hospitalization, if the last dose of antibiotics or the hospital discharge date&#xD;
                  was within 3 months of the first day of dosing (Day1).&#xD;
&#xD;
               -  An acute or chronic infection requiring treatment with oral antibiotics or&#xD;
                  antiviral medications, if the last dose was received within 4 weeks of the first&#xD;
                  day of dosing (Day1).&#xD;
&#xD;
               -  Any active or unresolved bacterial, viral or fungal infection present on the&#xD;
                  first day of dosing (Day1), whether requiring treatment or not. This does not&#xD;
                  include fungal nail infections.&#xD;
&#xD;
               -  Active or past osteomyelitis, unless fully resolved in the opinion of the&#xD;
                  investigator.&#xD;
&#xD;
               -  Symptomatic herpes zoster that has not resolved by 3 months prior to the first&#xD;
                  day of dosing (Day1).&#xD;
&#xD;
               -  History of Tuberculosis (TB) or a positive QuantiFERON-TB Gold test or&#xD;
                  QuantiFERON-TB Gold PLUS test at screening.&#xD;
&#xD;
          -  If the QuantiFERON-TB Gold test or QuantiFERON-TB Gold PLUS test is indeterminate, it&#xD;
             can be repeated once. A participant will not be eligible unless the second test is&#xD;
             negative or they have a negative tuberculin skin test (defined as skin induration &lt;5&#xD;
             mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin or other vaccination&#xD;
             history).&#xD;
&#xD;
          -  There must be no other clinical evidence of TB on physical examination of the&#xD;
             participant (screening examination).&#xD;
&#xD;
          -  Alanine transferase (ALT) &gt;2 times upper limit of normal (ULN) at screening.&#xD;
&#xD;
          -  Bilirubin &gt;1.5 times ULN at screening (isolated bilirubin &gt;1.5 times ULN is acceptable&#xD;
             if bilirubin is fractionated and direct bilirubin &lt;35 percentage).&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of gilbert's syndrome or asymptomatic gallstones). Participants&#xD;
             with evidence of liver fat on imaging but who are otherwise eligible for the study&#xD;
             criteria may be enrolled.&#xD;
&#xD;
          -  QTc &gt;480 milliseconds (msec) or QTc &gt;500 msec in participants with bundle branch block&#xD;
             at screening.&#xD;
&#xD;
          -  A history of carcinoma in situ and malignant disease, with the exception of basal cell&#xD;
             carcinoma that has been completely excised prior to the study.&#xD;
&#xD;
          -  Treatment with methotrexate within 3 months prior to the first dosing day (Day 1).&#xD;
&#xD;
          -  Previous or planned bone marrow transplant (e.g. autologous stem cell transplant).&#xD;
&#xD;
          -  Treatment with a biologic within the following timeframes:&#xD;
&#xD;
               -  Tocilizumab, abatacept or anti- tumor necrosis factor (including etanercept,&#xD;
                  infliximab, certolizumab, golimumab or adalimumab) within 3 months prior to the&#xD;
                  first dosing day (Day 1).&#xD;
&#xD;
               -  Rituximab within 12 months prior to the first dosing day (Day 1).&#xD;
&#xD;
               -  For any other biologic consult the medical monitor.&#xD;
&#xD;
          -  Treatment with oral or intravenous cyclophosphamide within 6 months prior to the first&#xD;
             dosing day (Day 1).&#xD;
&#xD;
          -  Treatment with any other non-biologic systemic immunosuppressive medication (e.g.&#xD;
             azathioprine, tacrolimus, ciclosporin) not mentioned above within 4 weeks prior to the&#xD;
             first dosing day (Day 1), with the exception of mycophenolate and permitted oral&#xD;
             corticosteroid.&#xD;
&#xD;
          -  Treatment with topical immunosuppressive medications (e.g. topical corticosteroids,&#xD;
             tacrolimus) within 1 week prior to the first dosing day (Day 1).&#xD;
&#xD;
          -  Treatment with intravenous prostanoids (e.g. iloprost) within 2 weeks prior to the&#xD;
             first dosing day (Day 1) or planned treatment before the Day 85 (Week 12) visit.&#xD;
&#xD;
          -  Treatment with anti-fibrotic medications including tyrosine kinase inhibitors (e.g.&#xD;
             nintedinib and imatinib) and pirfenidone within 3 months prior to the first dosing day&#xD;
             (Day 1).&#xD;
&#xD;
          -  Live vaccine(s) within 4 weeks prior to the first dosing day (Day 1), or plans to&#xD;
             receive such vaccines during the study.&#xD;
&#xD;
          -  Treatment with anti-coagulant medications, including warfarin, heparin, thrombin&#xD;
             inhibitors, and factor Xa inhibitors within 2 weeks prior to the first dosing day (Day&#xD;
             1).&#xD;
&#xD;
          -  Treatment with anti-platelet medications (e.g. clopidogrel, prasugrel, ticagrelor and&#xD;
             dipyridamole) within 2 weeks prior to first dosing day (Day 1). This does not include&#xD;
             aspirin at doses of 150 mg or less, or non-steroidal anti-inflammatory drugs, which&#xD;
             are permitted.&#xD;
&#xD;
          -  Current enrollment or past participation within the last 30 days before signing of&#xD;
             consent in any other clinical study involving an investigational study treatment.&#xD;
&#xD;
          -  Exposure to more than 4 new chemical entities within 12 months prior to the first&#xD;
             dosing day (Day 1).&#xD;
&#xD;
          -  Any of the following at screening:&#xD;
&#xD;
               -  Hemoglobin &lt;110 gram (g)/L&#xD;
&#xD;
               -  Platelet count &lt;150x10^9/L&#xD;
&#xD;
               -  Estimated glomerular filtration rate (GFR) (modification of diet in renal disease&#xD;
                  [MDRD] calculation) of &lt;45 mL/minute/1.73m^2&#xD;
&#xD;
          -  A positive human immunodeficiency virus (HIV) antibody test at screening.&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen (HBsAg) at screening.&#xD;
&#xD;
          -  Positive hepatitis B core antibody (HBcAb) test at screening.&#xD;
&#xD;
          -  Positive hepatitis C antibody test result at screening or within 3 months prior to&#xD;
             starting study treatment.&#xD;
&#xD;
          -  Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3&#xD;
             months prior to first dose of study treatment.&#xD;
&#xD;
          -  Sensitivity to any of the study treatments or components thereof, or other allergy&#xD;
             that in the opinion of the investigator, contraindicates participation in the study.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of a volume of 500 mL during the study.&#xD;
&#xD;
          -  A history of drug and alcohol misuse that could interfere with participation in the&#xD;
             trial according to the protocol, or in the opinion of the investigator impacts on the&#xD;
             physical or mental wellbeing of the participant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</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_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>April 29, 2021</results_first_submitted>
  <results_first_submitted_qc>April 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2021</results_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Sclerosis</keyword>
  <keyword>Repeat-dose</keyword>
  <keyword>Phase IIA</keyword>
  <keyword>GSK2330811</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Proof of mechanism study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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 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>April 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03041025/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>August 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03041025/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a randomized, double-blind (sponsor open), proof of mechanism study of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. This study was conducted in Canada, Netherlands, United Kingdom and United States.</recruitment_details>
      <pre_assignment_details>A total of 35 participants were enrolled in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="P2">
          <title>GSK2330811 100 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="P3">
          <title>GSK2330811 300 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="22"/>
              </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="2"/>
              </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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="B2">
          <title>GSK2330811 100 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="B3">
          <title>GSK2330811 300 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="B4">
          <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="8"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="35"/>
          </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="50.8" spread="15.42"/>
                    <measurement group_id="B2" value="66.7" spread="4.73"/>
                    <measurement group_id="B3" value="52.6" spread="12.59"/>
                    <measurement group_id="B4" value="53.4" spread="13.24"/>
                  </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="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" 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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian - East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White - White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse event (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. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.</description>
        <time_frame>Up to Day 197, but protocol allowed for additional events to be collected; up to Day 603 post first dose</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse event (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. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.</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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count</title>
        <description>Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count</title>
          <description>Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Giga cells 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: Basophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.0262"/>
                    <measurement group_id="O2" value="0.013" spread="0.0252"/>
                    <measurement group_id="O3" value="0.007" spread="0.0325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Basophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.0288"/>
                    <measurement group_id="O2" value="-0.003" spread="0.0252"/>
                    <measurement group_id="O3" value="0.003" spread="0.0350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Basophils, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.0169"/>
                    <measurement group_id="O2" value="0.027" spread="0.0635"/>
                    <measurement group_id="O3" value="-0.005" spread="0.0323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Basophils, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.0167"/>
                    <measurement group_id="O2" value="0.013" spread="0.0404"/>
                    <measurement group_id="O3" value="-0.004" spread="0.0333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Basophils, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.0267"/>
                    <measurement group_id="O2" value="-0.003" spread="0.0208"/>
                    <measurement group_id="O3" value="-0.008" spread="0.0341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Basophils, n=7,2,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.020" spread="0.0294"/>
                    <measurement group_id="O2" value="0.045" spread="0.0636"/>
                    <measurement group_id="O3" value="0.000" spread="0.0344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Basophils, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.0237"/>
                    <measurement group_id="O2" value="0.040" spread="0.0693"/>
                    <measurement group_id="O3" value="-0.002" spread="0.0390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Basophils, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004" spread="0.0270"/>
                    <measurement group_id="O2" value="0.060" spread="0.0721"/>
                    <measurement group_id="O3" value="0.000" spread="0.0400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Basophils, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.0399"/>
                    <measurement group_id="O2" value="0.033" spread="0.0208"/>
                    <measurement group_id="O3" value="0.015" spread="0.0517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Eosinophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.016" spread="0.0616"/>
                    <measurement group_id="O2" value="0.070" spread="0.0700"/>
                    <measurement group_id="O3" value="0.084" spread="0.2934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Eosinophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.036" spread="0.0901"/>
                    <measurement group_id="O2" value="0.060" spread="0.2007"/>
                    <measurement group_id="O3" value="0.001" spread="0.1633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Eosinophils, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.019" spread="0.0500"/>
                    <measurement group_id="O2" value="0.103" spread="0.1026"/>
                    <measurement group_id="O3" value="-0.015" spread="0.1954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Eosinophils, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.010" spread="0.0473"/>
                    <measurement group_id="O2" value="0.113" spread="0.1795"/>
                    <measurement group_id="O3" value="-0.034" spread="0.1797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Eosinophils, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.018" spread="0.0440"/>
                    <measurement group_id="O2" value="0.137" spread="0.2344"/>
                    <measurement group_id="O3" value="0.012" spread="0.1241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Eosinophils, n=7,2,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001" spread="0.0406"/>
                    <measurement group_id="O2" value="0.130" spread="0.3111"/>
                    <measurement group_id="O3" value="-0.035" spread="0.1773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Eosinophils, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.056" spread="0.1005"/>
                    <measurement group_id="O2" value="0.070" spread="0.0872"/>
                    <measurement group_id="O3" value="0.087" spread="0.2873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Eosinophils, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" spread="0.0403"/>
                    <measurement group_id="O2" value="0.080" spread="0.0300"/>
                    <measurement group_id="O3" value="0.005" spread="0.1695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Eosinophils, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.069" spread="0.1426"/>
                    <measurement group_id="O2" value="0.170" spread="0.1323"/>
                    <measurement group_id="O3" value="0.056" spread="0.1302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Lymphocytes, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.116" spread="0.3926"/>
                    <measurement group_id="O2" value="0.103" spread="0.3955"/>
                    <measurement group_id="O3" value="-0.125" spread="0.4110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Lymphocytes, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.064" spread="0.2539"/>
                    <measurement group_id="O2" value="0.477" spread="0.4177"/>
                    <measurement group_id="O3" value="-0.102" spread="0.6071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Lymphocytes, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.020" spread="0.2891"/>
                    <measurement group_id="O2" value="0.530" spread="0.3270"/>
                    <measurement group_id="O3" value="-0.078" spread="0.6156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Lymphocytes, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.043" spread="0.3732"/>
                    <measurement group_id="O2" value="0.563" spread="0.3798"/>
                    <measurement group_id="O3" value="0.105" spread="0.5853"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Lymphocytes, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.060" spread="0.2384"/>
                    <measurement group_id="O2" value="0.430" spread="0.3601"/>
                    <measurement group_id="O3" value="0.155" spread="0.5169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Lymphocytes, n=7,2,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.109" spread="0.2202"/>
                    <measurement group_id="O2" value="0.580" spread="0.4667"/>
                    <measurement group_id="O3" value="0.313" spread="0.5521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Lymphocytes, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.297" spread="0.5087"/>
                    <measurement group_id="O2" value="0.383" spread="0.3907"/>
                    <measurement group_id="O3" value="0.287" spread="0.6783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Lymphocytes, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.046" spread="0.2327"/>
                    <measurement group_id="O2" value="0.160" spread="0.2600"/>
                    <measurement group_id="O3" value="0.202" spread="0.4504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Lymphocytes, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.066" spread="0.4108"/>
                    <measurement group_id="O2" value="-0.010" spread="0.4419"/>
                    <measurement group_id="O3" value="0.039" spread="0.7780"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Monocytes, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.096" spread="0.1507"/>
                    <measurement group_id="O2" value="-0.017" spread="0.1102"/>
                    <measurement group_id="O3" value="-0.051" spread="0.1659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Monocytes, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.006" spread="0.0578"/>
                    <measurement group_id="O2" value="-0.030" spread="0.3959"/>
                    <measurement group_id="O3" value="-0.120" spread="0.2175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Monocytes, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.103" spread="0.2093"/>
                    <measurement group_id="O2" value="0.047" spread="0.1069"/>
                    <measurement group_id="O3" value="-0.106" spread="0.2045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Monocytes, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.037" spread="0.0698"/>
                    <measurement group_id="O2" value="-0.120" spread="0.1600"/>
                    <measurement group_id="O3" value="-0.130" spread="0.2216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Monocytes, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.050" spread="0.1414"/>
                    <measurement group_id="O2" value="-0.003" spread="0.0404"/>
                    <measurement group_id="O3" value="-0.070" spread="0.1838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Monocytes, n=7,2,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.0652"/>
                    <measurement group_id="O2" value="0.140" spread="0.1697"/>
                    <measurement group_id="O3" value="-0.127" spread="0.2495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Monocytes, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.070" spread="0.1494"/>
                    <measurement group_id="O2" value="0.030" spread="0.1735"/>
                    <measurement group_id="O3" value="-0.028" spread="0.2246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Monocytes, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.064" spread="0.1229"/>
                    <measurement group_id="O2" value="0.167" spread="0.1250"/>
                    <measurement group_id="O3" value="-0.022" spread="0.1414"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Monocytes, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.051" spread="0.2242"/>
                    <measurement group_id="O2" value="-0.043" spread="0.1266"/>
                    <measurement group_id="O3" value="-0.053" spread="0.2234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Total neutrophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.228" spread="1.3240"/>
                    <measurement group_id="O2" value="1.060" spread="3.0143"/>
                    <measurement group_id="O3" value="-0.917" spread="1.4114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Total neutrophils, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.318" spread="1.4309"/>
                    <measurement group_id="O2" value="0.323" spread="1.8591"/>
                    <measurement group_id="O3" value="-1.104" spread="1.4251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Total neutrophils, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.315" spread="1.3403"/>
                    <measurement group_id="O2" value="-0.350" spread="1.4731"/>
                    <measurement group_id="O3" value="-1.406" spread="1.4631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Total neutrophils, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.538" spread="0.9156"/>
                    <measurement group_id="O2" value="-0.517" spread="1.9998"/>
                    <measurement group_id="O3" value="-1.387" spread="1.4428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Total neutrophils, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.789" spread="2.1739"/>
                    <measurement group_id="O2" value="-0.223" spread="1.8928"/>
                    <measurement group_id="O3" value="-1.369" spread="1.6361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Total neutrophils, n=7,2,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.139" spread="1.1995"/>
                    <measurement group_id="O2" value="-0.990" spread="2.9698"/>
                    <measurement group_id="O3" value="-1.424" spread="2.3949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Total neutrophils, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.680" spread="1.2472"/>
                    <measurement group_id="O2" value="-0.263" spread="1.0384"/>
                    <measurement group_id="O3" value="-1.002" spread="1.5195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Total neutrophils, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.027" spread="1.2229"/>
                    <measurement group_id="O2" value="-0.673" spread="2.1324"/>
                    <measurement group_id="O3" value="-0.183" spread="1.2208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Total neutrophils, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.317" spread="1.3578"/>
                    <measurement group_id="O2" value="-1.603" spread="4.0868"/>
                    <measurement group_id="O3" value="-0.001" spread="1.4937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Platelet count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="24.02"/>
                    <measurement group_id="O2" value="-42.0" spread="32.70"/>
                    <measurement group_id="O3" value="-124.6" spread="87.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Platelet count, n=7,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="20.38"/>
                    <measurement group_id="O2" value="-39.7" spread="29.28"/>
                    <measurement group_id="O3" value="-145.7" spread="94.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Platelet count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.1" spread="14.56"/>
                    <measurement group_id="O2" value="-49.0" spread="22.27"/>
                    <measurement group_id="O3" value="-150.2" spread="90.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Platelet count, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="20.40"/>
                    <measurement group_id="O2" value="-66.0" spread="42.04"/>
                    <measurement group_id="O3" value="-148.6" spread="90.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Platelet count, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" spread="17.67"/>
                    <measurement group_id="O2" value="-41.7" spread="45.21"/>
                    <measurement group_id="O3" value="-129.4" spread="90.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Platelet count, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.0" spread="25.89"/>
                    <measurement group_id="O2" value="-48.0" spread="29.10"/>
                    <measurement group_id="O3" value="-97.4" spread="73.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Platelet count, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.4" spread="25.53"/>
                    <measurement group_id="O2" value="-20.3" spread="42.52"/>
                    <measurement group_id="O3" value="-61.2" spread="96.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Platelet count, n=6,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.7" spread="19.62"/>
                    <measurement group_id="O2" value="15.0" spread="31.24"/>
                    <measurement group_id="O3" value="-6.9" spread="60.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Platelet count, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="30.30"/>
                    <measurement group_id="O2" value="-20.7" spread="71.53"/>
                    <measurement group_id="O3" value="-10.3" spread="42.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: WBC count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="1.546"/>
                    <measurement group_id="O2" value="1.20" spread="2.685"/>
                    <measurement group_id="O3" value="-1.00" spread="1.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: WBC count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="1.400"/>
                    <measurement group_id="O2" value="0.80" spread="1.212"/>
                    <measurement group_id="O3" value="-1.33" spread="1.927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: WBC count, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="1.418"/>
                    <measurement group_id="O2" value="0.33" spread="0.950"/>
                    <measurement group_id="O3" value="-1.60" spread="2.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: WBC count, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.774"/>
                    <measurement group_id="O2" value="0.03" spread="1.617"/>
                    <measurement group_id="O3" value="-1.46" spread="1.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: WBC count, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="2.191"/>
                    <measurement group_id="O2" value="0.33" spread="1.258"/>
                    <measurement group_id="O3" value="-1.29" spread="1.953"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: WBC count, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="1.182"/>
                    <measurement group_id="O2" value="-0.10" spread="1.400"/>
                    <measurement group_id="O3" value="-1.27" spread="2.509"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: WBC count, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="1.138"/>
                    <measurement group_id="O2" value="0.27" spread="0.473"/>
                    <measurement group_id="O3" value="-0.61" spread="1.913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: WBC count, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.228"/>
                    <measurement group_id="O2" value="-0.20" spread="1.778"/>
                    <measurement group_id="O3" value="0.01" spread="1.571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: WBC count, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="1.469"/>
                    <measurement group_id="O2" value="-1.50" spread="4.444"/>
                    <measurement group_id="O3" value="-0.01" spread="1.948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)</title>
        <description>Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)</title>
          <description>Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Grams 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: Hemoglobin, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="8.89"/>
                    <measurement group_id="O2" value="2.0" spread="7.00"/>
                    <measurement group_id="O3" value="-0.2" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Hemoglobin, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="6.55"/>
                    <measurement group_id="O2" value="-0.7" spread="11.06"/>
                    <measurement group_id="O3" value="-3.7" spread="7.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Hemoglobin, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="6.39"/>
                    <measurement group_id="O2" value="-1.7" spread="8.50"/>
                    <measurement group_id="O3" value="-7.7" spread="9.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Hemoglobin, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="8.47"/>
                    <measurement group_id="O2" value="-2.7" spread="11.15"/>
                    <measurement group_id="O3" value="-13.7" spread="12.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Hemoglobin, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="10.38"/>
                    <measurement group_id="O2" value="-6.3" spread="4.73"/>
                    <measurement group_id="O3" value="-21.2" spread="11.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Hemoglobin, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="7.58"/>
                    <measurement group_id="O2" value="-10.7" spread="6.11"/>
                    <measurement group_id="O3" value="-22.0" spread="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Hemoglobin, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="8.43"/>
                    <measurement group_id="O2" value="-9.0" spread="7.55"/>
                    <measurement group_id="O3" value="-21.3" spread="10.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Hemoglobin, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="9.41"/>
                    <measurement group_id="O2" value="-7.3" spread="6.03"/>
                    <measurement group_id="O3" value="-14.3" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Hemoglobin, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="8.88"/>
                    <measurement group_id="O2" value="-6.7" spread="2.08"/>
                    <measurement group_id="O3" value="-5.8" spread="6.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: MCHC, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="8.53"/>
                    <measurement group_id="O2" value="-5.0" spread="3.00"/>
                    <measurement group_id="O3" value="2.4" spread="7.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: MCHC, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="6.39"/>
                    <measurement group_id="O2" value="2.0" spread="13.11"/>
                    <measurement group_id="O3" value="2.0" spread="8.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: MCHC, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="9.27"/>
                    <measurement group_id="O2" value="1.0" spread="7.55"/>
                    <measurement group_id="O3" value="2.5" spread="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: MCHC, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="10.11"/>
                    <measurement group_id="O2" value="3.7" spread="4.93"/>
                    <measurement group_id="O3" value="2.8" spread="8.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: MCHC, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="12.87"/>
                    <measurement group_id="O2" value="2.7" spread="6.81"/>
                    <measurement group_id="O3" value="0.5" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: MCHC, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="10.53"/>
                    <measurement group_id="O2" value="-1.7" spread="9.50"/>
                    <measurement group_id="O3" value="2.8" spread="6.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: MCHC, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="7.18"/>
                    <measurement group_id="O2" value="5.0" spread="8.19"/>
                    <measurement group_id="O3" value="-3.3" spread="8.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: MCHC, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="5.26"/>
                    <measurement group_id="O2" value="3.7" spread="4.16"/>
                    <measurement group_id="O3" value="-4.2" spread="9.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: MCHC, n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="8.58"/>
                    <measurement group_id="O2" value="-0.3" spread="7.02"/>
                    <measurement group_id="O3" value="-3.5" spread="8.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameter: Hematocrit</title>
        <description>Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameter: Hematocrit</title>
          <description>Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Proportion of red blood cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0089" spread="0.02744"/>
                    <measurement group_id="O2" value="0.0127" spread="0.02203"/>
                    <measurement group_id="O3" value="-0.0035" spread="0.01771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0023" spread="0.01955"/>
                    <measurement group_id="O2" value="-0.0027" spread="0.04234"/>
                    <measurement group_id="O3" value="-0.0141" spread="0.02486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0049" spread="0.01788"/>
                    <measurement group_id="O2" value="-0.0057" spread="0.03564"/>
                    <measurement group_id="O3" value="-0.0271" spread="0.03187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0092" spread="0.02500"/>
                    <measurement group_id="O2" value="-0.0120" spread="0.03274"/>
                    <measurement group_id="O3" value="-0.0444" spread="0.04224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0146" spread="0.02870"/>
                    <measurement group_id="O2" value="-0.0217" spread="0.02329"/>
                    <measurement group_id="O3" value="-0.0637" spread="0.03983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0151" spread="0.02591"/>
                    <measurement group_id="O2" value="-0.0300" spread="0.01803"/>
                    <measurement group_id="O3" value="-0.0688" spread="0.03265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0141" spread="0.03007"/>
                    <measurement group_id="O2" value="-0.0323" spread="0.02822"/>
                    <measurement group_id="O3" value="-0.0602" spread="0.02839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0164" spread="0.03169"/>
                    <measurement group_id="O2" value="-0.0263" spread="0.01626"/>
                    <measurement group_id="O3" value="-0.0349" spread="0.02482"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0111" spread="0.02634"/>
                    <measurement group_id="O2" value="-0.0193" spread="0.00981"/>
                    <measurement group_id="O3" value="-0.0125" spread="0.02252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH)</title>
        <description>Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH)</title>
          <description>Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Picogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.711"/>
                    <measurement group_id="O2" value="0.03" spread="0.493"/>
                    <measurement group_id="O3" value="0.04" spread="0.503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.616"/>
                    <measurement group_id="O2" value="0.37" spread="0.709"/>
                    <measurement group_id="O3" value="-0.23" spread="0.437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.807"/>
                    <measurement group_id="O2" value="-0.10" spread="0.173"/>
                    <measurement group_id="O3" value="-0.41" spread="0.450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.750"/>
                    <measurement group_id="O2" value="0.10" spread="0.361"/>
                    <measurement group_id="O3" value="-0.39" spread="0.493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.945"/>
                    <measurement group_id="O2" value="0.17" spread="0.379"/>
                    <measurement group_id="O3" value="-0.50" spread="0.503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.034"/>
                    <measurement group_id="O2" value="-0.30" spread="0.755"/>
                    <measurement group_id="O3" value="-0.45" spread="0.709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.808"/>
                    <measurement group_id="O2" value="0.87" spread="0.513"/>
                    <measurement group_id="O3" value="-0.27" spread="0.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.637"/>
                    <measurement group_id="O2" value="0.90" spread="0.200"/>
                    <measurement group_id="O3" value="0.04" spread="1.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="1.015"/>
                    <measurement group_id="O2" value="0.33" spread="0.208"/>
                    <measurement group_id="O3" value="-0.23" spread="1.285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV)</title>
        <description>Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV)</title>
          <description>Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Femtoliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: MCV, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.63" spread="1.188"/>
                    <measurement group_id="O2" value="1.33" spread="1.528"/>
                    <measurement group_id="O3" value="-0.39" spread="1.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: MCV, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="1.188"/>
                    <measurement group_id="O2" value="0.33" spread="1.155"/>
                    <measurement group_id="O3" value="-1.17" spread="2.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: MCV, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="2.326"/>
                    <measurement group_id="O2" value="-0.67" spread="1.528"/>
                    <measurement group_id="O3" value="-1.86" spread="1.583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: MCV, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="2.787"/>
                    <measurement group_id="O2" value="-1.00" spread="0.000"/>
                    <measurement group_id="O3" value="-1.77" spread="2.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: MCV, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="3.441"/>
                    <measurement group_id="O2" value="-0.67" spread="1.528"/>
                    <measurement group_id="O3" value="-1.60" spread="2.722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: MCV, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="1.113"/>
                    <measurement group_id="O2" value="-0.67" spread="0.577"/>
                    <measurement group_id="O3" value="-2.05" spread="2.478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: MCV, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="2.563"/>
                    <measurement group_id="O2" value="1.00" spread="1.732"/>
                    <measurement group_id="O3" value="0.00" spread="3.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: MCV, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="1.215"/>
                    <measurement group_id="O2" value="1.67" spread="0.577"/>
                    <measurement group_id="O3" value="1.26" spread="4.584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: MCV, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="1.799"/>
                    <measurement group_id="O2" value="0.67" spread="2.082"/>
                    <measurement group_id="O3" value="-0.02" spread="3.575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: MPV, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.256"/>
                    <measurement group_id="O2" value="0.20" spread="0.361"/>
                    <measurement group_id="O3" value="0.45" spread="0.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: MPV, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.378"/>
                    <measurement group_id="O2" value="0.47" spread="0.764"/>
                    <measurement group_id="O3" value="0.29" spread="0.630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: MPV, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.276"/>
                    <measurement group_id="O2" value="0.23" spread="0.737"/>
                    <measurement group_id="O3" value="0.07" spread="0.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: MPV, n=6,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.446"/>
                    <measurement group_id="O2" value="0.47" spread="0.416"/>
                    <measurement group_id="O3" value="0.12" spread="0.599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: MPV, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.393"/>
                    <measurement group_id="O2" value="0.23" spread="0.231"/>
                    <measurement group_id="O3" value="-0.15" spread="0.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: MPV, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.356"/>
                    <measurement group_id="O2" value="0.43" spread="0.808"/>
                    <measurement group_id="O3" value="-0.11" spread="0.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: MPV, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.443"/>
                    <measurement group_id="O2" value="0.30" spread="0.781"/>
                    <measurement group_id="O3" value="0.03" spread="0.622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: MPV, n=6,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.565"/>
                    <measurement group_id="O2" value="0.10" spread="0.872"/>
                    <measurement group_id="O3" value="0.01" spread="0.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: MPV, n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.385"/>
                    <measurement group_id="O2" value="0.10" spread="0.781"/>
                    <measurement group_id="O3" value="0.07" spread="0.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count</title>
        <description>Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count</title>
          <description>Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Tera cells 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: RBC count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.321"/>
                    <measurement group_id="O2" value="0.07" spread="0.208"/>
                    <measurement group_id="O3" value="-0.01" spread="0.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: RBC count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.225"/>
                    <measurement group_id="O2" value="-0.07" spread="0.404"/>
                    <measurement group_id="O3" value="-0.11" spread="0.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: RBC count, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.238"/>
                    <measurement group_id="O2" value="-0.07" spread="0.321"/>
                    <measurement group_id="O3" value="-0.22" spread="0.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: RBC count, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.288"/>
                    <measurement group_id="O2" value="-0.10" spread="0.361"/>
                    <measurement group_id="O3" value="-0.42" spread="0.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: RBC count, n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.396"/>
                    <measurement group_id="O2" value="-0.23" spread="0.208"/>
                    <measurement group_id="O3" value="-0.66" spread="0.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: RBC count, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.311"/>
                    <measurement group_id="O2" value="-0.33" spread="0.208"/>
                    <measurement group_id="O3" value="-0.68" spread="0.343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: RBC count, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.350"/>
                    <measurement group_id="O2" value="-0.40" spread="0.265"/>
                    <measurement group_id="O3" value="-0.68" spread="0.361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: RBC count, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.330"/>
                    <measurement group_id="O2" value="-0.37" spread="0.252"/>
                    <measurement group_id="O3" value="-0.47" spread="0.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: RBC count, n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.282"/>
                    <measurement group_id="O2" value="-0.23" spread="0.058"/>
                    <measurement group_id="O3" value="-0.15" spread="0.160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Reticulocyte count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0109" spread="0.02401"/>
                    <measurement group_id="O2" value="-0.0207" spread="0.02463"/>
                    <measurement group_id="O3" value="-0.0160" spread="0.00964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Reticulocyte count, n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0001" spread="0.00543"/>
                    <measurement group_id="O2" value="-0.0169" spread="0.00911"/>
                    <measurement group_id="O3" value="-0.0132" spread="0.01784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Reticulocyte count, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0032" spread="0.00554"/>
                    <measurement group_id="O2" value="-0.0228" spread="0.02303"/>
                    <measurement group_id="O3" value="-0.0109" spread="0.01699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Reticulocyte count, n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0058" spread="0.00638"/>
                    <measurement group_id="O2" value="-0.0091" spread="0.02177"/>
                    <measurement group_id="O3" value="-0.0031" spread="0.01656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Reticulocyte count, n=8,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0026" spread="0.01261"/>
                    <measurement group_id="O2" value="-0.0125" spread="0.01878"/>
                    <measurement group_id="O3" value="0.0065" spread="0.01934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Reticulocyte count, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0044" spread="0.00539"/>
                    <measurement group_id="O2" value="-0.0209" spread="0.02471"/>
                    <measurement group_id="O3" value="0.0152" spread="0.02006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Reticulocyte count, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0064" spread="0.01030"/>
                    <measurement group_id="O2" value="0.0012" spread="0.02944"/>
                    <measurement group_id="O3" value="0.0356" spread="0.02009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Reticulocyte count, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0006" spread="0.00623"/>
                    <measurement group_id="O2" value="-0.0157" spread="0.02263"/>
                    <measurement group_id="O3" value="0.0158" spread="0.01340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Reticulocyte count, n=7,3,16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0003" spread="0.00550"/>
                    <measurement group_id="O2" value="-0.0285" spread="0.03458"/>
                    <measurement group_id="O3" value="0.0017" spread="0.01003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW)</title>
        <description>Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW)</title>
          <description>Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Percentage of width</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.711"/>
                    <measurement group_id="O2" value="-0.27" spread="1.050"/>
                    <measurement group_id="O3" value="-0.26" spread="0.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.417"/>
                    <measurement group_id="O2" value="-0.53" spread="1.704"/>
                    <measurement group_id="O3" value="-0.47" spread="1.036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.583"/>
                    <measurement group_id="O2" value="-0.97" spread="1.650"/>
                    <measurement group_id="O3" value="-0.47" spread="1.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.578"/>
                    <measurement group_id="O2" value="-0.83" spread="2.248"/>
                    <measurement group_id="O3" value="0.15" spread="1.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.725"/>
                    <measurement group_id="O2" value="-0.23" spread="2.570"/>
                    <measurement group_id="O3" value="0.96" spread="2.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.663"/>
                    <measurement group_id="O2" value="-0.20" spread="2.307"/>
                    <measurement group_id="O3" value="1.67" spread="1.792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.748"/>
                    <measurement group_id="O2" value="0.73" spread="1.950"/>
                    <measurement group_id="O3" value="4.24" spread="2.737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.771"/>
                    <measurement group_id="O2" value="0.10" spread="1.916"/>
                    <measurement group_id="O3" value="2.86" spread="1.636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.286"/>
                    <measurement group_id="O2" value="-0.57" spread="1.872"/>
                    <measurement group_id="O3" value="1.06" spread="1.375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Reticulocyte Production Index</title>
        <description>Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent [%]) multiply by (x) (hematocrit [%] divided by [/] 45) x 1/ reticulocyte maturation time'.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Reticulocyte Production Index</title>
          <description>Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent [%]) multiply by (x) (hematocrit [%] divided by [/] 45) x 1/ reticulocyte maturation time'.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Unitless</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2009" spread="0.49644"/>
                    <measurement group_id="O2" value="-0.1787" spread="0.53867"/>
                    <measurement group_id="O3" value="-0.2757" spread="0.20191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0391" spread="0.09687"/>
                    <measurement group_id="O2" value="-0.2397" spread="0.51850"/>
                    <measurement group_id="O3" value="-0.2460" spread="0.35460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0691" spread="0.11447"/>
                    <measurement group_id="O2" value="-0.3437" spread="0.55192"/>
                    <measurement group_id="O3" value="-0.2342" spread="0.34389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0763" spread="0.13476"/>
                    <measurement group_id="O2" value="-0.2877" spread="0.48015"/>
                    <measurement group_id="O3" value="-0.1933" spread="0.32326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0154" spread="0.24560"/>
                    <measurement group_id="O2" value="-0.4643" spread="0.13444"/>
                    <measurement group_id="O3" value="-0.1344" spread="0.29111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0831" spread="0.14906"/>
                    <measurement group_id="O2" value="-0.4530" spread="0.48914"/>
                    <measurement group_id="O3" value="-0.0112" spread="0.32736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1006" spread="0.21168"/>
                    <measurement group_id="O2" value="-0.2633" spread="0.29016"/>
                    <measurement group_id="O3" value="0.2826" spread="0.33003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0033" spread="0.24087"/>
                    <measurement group_id="O2" value="-0.4720" spread="0.24857"/>
                    <measurement group_id="O3" value="0.1105" spread="0.28718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0296" spread="0.11222"/>
                    <measurement group_id="O2" value="-0.5693" spread="0.43160"/>
                    <measurement group_id="O3" value="0.0087" spread="0.16995"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Hematology Parameter: Reticulocytes</title>
        <description>Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Hematology Parameter: Reticulocytes</title>
          <description>Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Percentage of reticulocytes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0026" spread="0.00534"/>
                    <measurement group_id="O2" value="-0.0053" spread="0.00551"/>
                    <measurement group_id="O3" value="-0.0037" spread="0.00236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0001" spread="0.00155"/>
                    <measurement group_id="O2" value="-0.0040" spread="0.00265"/>
                    <measurement group_id="O3" value="-0.0030" spread="0.00423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0008" spread="0.00128"/>
                    <measurement group_id="O2" value="-0.0057" spread="0.00611"/>
                    <measurement group_id="O3" value="-0.0021" spread="0.00389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=6,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0012" spread="0.00214"/>
                    <measurement group_id="O2" value="-0.0023" spread="0.00551"/>
                    <measurement group_id="O3" value="0.0004" spread="0.00422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0014" spread="0.00325"/>
                    <measurement group_id="O2" value="-0.0027" spread="0.00551"/>
                    <measurement group_id="O3" value="0.0037" spread="0.00625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0007" spread="0.00138"/>
                    <measurement group_id="O2" value="-0.0043" spread="0.00651"/>
                    <measurement group_id="O3" value="0.0065" spread="0.00647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0011" spread="0.00219"/>
                    <measurement group_id="O2" value="0.0013" spread="0.00702"/>
                    <measurement group_id="O3" value="0.0121" spread="0.00704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0006" spread="0.00162"/>
                    <measurement group_id="O2" value="-0.0027" spread="0.00603"/>
                    <measurement group_id="O3" value="0.0054" spread="0.00405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0001" spread="0.00157"/>
                    <measurement group_id="O2" value="-0.0063" spread="0.00924"/>
                    <measurement group_id="O3" value="0.0005" spread="0.00233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline</title>
        <description>Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: &lt;30 grams per liter (g/L) (albumin), high: &gt;44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: &lt;3 or high: &gt;9 mmol/L (glucose), low: &lt;3 or high: &gt;5.5 mmol/L (potassium), and low: &lt;130 or high: &gt;150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was 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 within Range or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add up to 100%.</description>
        <time_frame>Up to Day 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline</title>
          <description>Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: &lt;30 grams per liter (g/L) (albumin), high: &gt;44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: &lt;3 or high: &gt;9 mmol/L (glucose), low: &lt;3 or high: &gt;5.5 mmol/L (potassium), and low: &lt;130 or high: &gt;150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was 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 within Range or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add up to 100%.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin: To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin: To within Range or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin: To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: To within Range or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: To Low</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: To within Range or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: To within Range or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: To within Range or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameter: Total Protein</title>
        <description>Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameter: Total Protein</title>
          <description>Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Grams 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="3.06"/>
                    <measurement group_id="O2" value="0.5" spread="4.95"/>
                    <measurement group_id="O3" value="0.4" spread="3.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.14"/>
                    <measurement group_id="O2" value="-1.0" spread="5.66"/>
                    <measurement group_id="O3" value="0.7" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.36"/>
                    <measurement group_id="O2" value="-0.3" spread="2.08"/>
                    <measurement group_id="O3" value="-0.5" spread="3.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="2.29"/>
                    <measurement group_id="O2" value="1.3" spread="2.08"/>
                    <measurement group_id="O3" value="-0.5" spread="3.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.56"/>
                    <measurement group_id="O2" value="0.7" spread="1.15"/>
                    <measurement group_id="O3" value="-1.1" spread="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.39"/>
                    <measurement group_id="O2" value="0.0" spread="2.00"/>
                    <measurement group_id="O3" value="0.3" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.61"/>
                    <measurement group_id="O2" value="1.7" spread="0.58"/>
                    <measurement group_id="O3" value="0.2" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="1.25"/>
                    <measurement group_id="O2" value="3.0" spread="7.21"/>
                    <measurement group_id="O3" value="-0.1" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="3.90"/>
                    <measurement group_id="O2" value="2.3" spread="3.51"/>
                    <measurement group_id="O3" value="1.5" spread="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH)</title>
        <description>Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH)</title>
          <description>Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>International units 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: ALP, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="10.53"/>
                    <measurement group_id="O2" value="-1.0" spread="4.24"/>
                    <measurement group_id="O3" value="0.6" spread="5.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: ALP, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="7.89"/>
                    <measurement group_id="O2" value="4.5" spread="6.36"/>
                    <measurement group_id="O3" value="-1.1" spread="10.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: ALP, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="12.36"/>
                    <measurement group_id="O2" value="0.7" spread="7.51"/>
                    <measurement group_id="O3" value="-1.1" spread="9.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: ALP, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="13.23"/>
                    <measurement group_id="O2" value="3.3" spread="9.07"/>
                    <measurement group_id="O3" value="1.0" spread="7.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: ALP, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="10.94"/>
                    <measurement group_id="O2" value="1.3" spread="1.53"/>
                    <measurement group_id="O3" value="-3.0" spread="11.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: ALP, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="11.96"/>
                    <measurement group_id="O2" value="-2.3" spread="4.93"/>
                    <measurement group_id="O3" value="-3.0" spread="11.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: ALP, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="4.99"/>
                    <measurement group_id="O2" value="-2.3" spread="4.93"/>
                    <measurement group_id="O3" value="-6.3" spread="8.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: ALP, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="15.88"/>
                    <measurement group_id="O2" value="-3.3" spread="5.69"/>
                    <measurement group_id="O3" value="-5.4" spread="9.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: ALP, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="12.16"/>
                    <measurement group_id="O2" value="-4.0" spread="6.93"/>
                    <measurement group_id="O3" value="-2.1" spread="11.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: ALT, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="2.70"/>
                    <measurement group_id="O2" value="0.0" spread="1.41"/>
                    <measurement group_id="O3" value="1.6" spread="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: ALT, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.85"/>
                    <measurement group_id="O2" value="-2.0" spread="2.83"/>
                    <measurement group_id="O3" value="3.3" spread="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: ALT, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="3.15"/>
                    <measurement group_id="O2" value="4.0" spread="6.08"/>
                    <measurement group_id="O3" value="3.1" spread="10.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: ALT, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.27"/>
                    <measurement group_id="O2" value="2.0" spread="4.58"/>
                    <measurement group_id="O3" value="3.7" spread="10.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: ALT, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="2.82"/>
                    <measurement group_id="O2" value="3.0" spread="6.24"/>
                    <measurement group_id="O3" value="0.0" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: ALT, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.89"/>
                    <measurement group_id="O2" value="-0.3" spread="2.52"/>
                    <measurement group_id="O3" value="0.4" spread="4.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: ALT, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="5.13"/>
                    <measurement group_id="O2" value="4.7" spread="8.14"/>
                    <measurement group_id="O3" value="0.2" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: ALT, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="6.65"/>
                    <measurement group_id="O2" value="1.0" spread="1.00"/>
                    <measurement group_id="O3" value="0.9" spread="3.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: ALT, n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="3.87"/>
                    <measurement group_id="O2" value="-0.3" spread="2.52"/>
                    <measurement group_id="O3" value="2.4" spread="4.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: AST, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.77"/>
                    <measurement group_id="O2" value="0.5" spread="0.71"/>
                    <measurement group_id="O3" value="1.7" spread="5.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: AST, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="7.11"/>
                    <measurement group_id="O2" value="1.0" spread="1.41"/>
                    <measurement group_id="O3" value="2.0" spread="5.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: AST, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="6.74"/>
                    <measurement group_id="O2" value="2.0" spread="3.61"/>
                    <measurement group_id="O3" value="0.9" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: AST, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.82"/>
                    <measurement group_id="O2" value="2.3" spread="3.06"/>
                    <measurement group_id="O3" value="2.0" spread="5.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: AST, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="5.00"/>
                    <measurement group_id="O2" value="3.3" spread="4.93"/>
                    <measurement group_id="O3" value="-0.3" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: AST, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="4.37"/>
                    <measurement group_id="O2" value="0.3" spread="2.31"/>
                    <measurement group_id="O3" value="-0.2" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: AST, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="4.39"/>
                    <measurement group_id="O2" value="1.3" spread="4.04"/>
                    <measurement group_id="O3" value="-0.9" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: AST, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="7.70"/>
                    <measurement group_id="O2" value="2.3" spread="0.58"/>
                    <measurement group_id="O3" value="-0.6" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: AST, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="4.91"/>
                    <measurement group_id="O2" value="2.7" spread="0.58"/>
                    <measurement group_id="O3" value="1.2" spread="3.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: LDH, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="28.54"/>
                    <measurement group_id="O2" value="-3.5" spread="51.62"/>
                    <measurement group_id="O3" value="18.4" spread="32.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: LDH, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="14.95"/>
                    <measurement group_id="O2" value="11.0" spread="0.00"/>
                    <measurement group_id="O3" value="20.9" spread="22.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: LDH, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="11.54"/>
                    <measurement group_id="O2" value="2.7" spread="30.62"/>
                    <measurement group_id="O3" value="27.2" spread="34.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: LDH, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="19.36"/>
                    <measurement group_id="O2" value="15.3" spread="31.02"/>
                    <measurement group_id="O3" value="22.4" spread="23.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: LDH, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="29.62"/>
                    <measurement group_id="O2" value="13.3" spread="26.95"/>
                    <measurement group_id="O3" value="32.7" spread="29.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: LDH, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="26.26"/>
                    <measurement group_id="O2" value="3.0" spread="11.53"/>
                    <measurement group_id="O3" value="24.9" spread="28.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: LDH, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.6" spread="17.89"/>
                    <measurement group_id="O2" value="6.3" spread="25.50"/>
                    <measurement group_id="O3" value="14.2" spread="26.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: LDH, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.4" spread="32.67"/>
                    <measurement group_id="O2" value="1.0" spread="16.00"/>
                    <measurement group_id="O3" value="13.4" spread="12.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: LDH, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" spread="27.97"/>
                    <measurement group_id="O2" value="0.3" spread="20.60"/>
                    <measurement group_id="O3" value="16.1" spread="21.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin</title>
        <description>Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin</title>
          <description>Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: Total bilirubin, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.571" spread="2.2254"/>
                    <measurement group_id="O2" value="2.000" spread="2.8284"/>
                    <measurement group_id="O3" value="-0.957" spread="1.8944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Total bilirubin, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.000" spread="2.8284"/>
                    <measurement group_id="O2" value="-3.000" spread="1.4142"/>
                    <measurement group_id="O3" value="-0.087" spread="1.8565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Total bilirubin, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.500" spread="1.4142"/>
                    <measurement group_id="O2" value="-2.000" spread="2.0000"/>
                    <measurement group_id="O3" value="-0.364" spread="1.4653"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Total bilirubin, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.286" spread="1.3801"/>
                    <measurement group_id="O2" value="-2.000" spread="0.0000"/>
                    <measurement group_id="O3" value="-0.636" spread="2.0827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Total bilirubin, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.250" spread="1.9821"/>
                    <measurement group_id="O2" value="-1.333" spread="1.1547"/>
                    <measurement group_id="O3" value="-0.095" spread="2.1425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Total bilirubin, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.250" spread="2.7124"/>
                    <measurement group_id="O2" value="-2.000" spread="0.0000"/>
                    <measurement group_id="O3" value="-0.364" spread="1.8138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Total bilirubin, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="3.2660"/>
                    <measurement group_id="O2" value="-1.333" spread="1.1547"/>
                    <measurement group_id="O3" value="0.100" spread="1.5183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Total bilirubin, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.143" spread="3.0237"/>
                    <measurement group_id="O2" value="-3.333" spread="1.1547"/>
                    <measurement group_id="O3" value="-1.604" spread="2.4901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Total bilirubin, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.571" spread="2.7603"/>
                    <measurement group_id="O2" value="-4.000" spread="0.0000"/>
                    <measurement group_id="O3" value="-1.416" spread="1.6976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Direct bilirubin, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.4" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Direct bilirubin, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.71"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="0.0" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Direct bilirubin, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.71"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.2" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Direct bilirubin, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.4" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Direct bilirubin, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.71"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.1" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Direct bilirubin, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.71"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.2" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Direct bilirubin, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.15"/>
                    <measurement group_id="O2" value="-0.7" spread="1.15"/>
                    <measurement group_id="O3" value="-0.3" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Direct bilirubin, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.76"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.2" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Direct bilirubin, n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="-0.1" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides</title>
        <description>Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose) and Day 85</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides</title>
          <description>Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Millimoles 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cholesterol: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.125" spread="0.7474"/>
                    <measurement group_id="O2" value="0.067" spread="0.1258"/>
                    <measurement group_id="O3" value="0.450" spread="0.5780"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct HDL Cholesterol: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.093" spread="0.1718"/>
                    <measurement group_id="O2" value="-0.033" spread="0.0289"/>
                    <measurement group_id="O3" value="-0.036" spread="0.2989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol: n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.091" spread="0.7376"/>
                    <measurement group_id="O2" value="0.110" spread="0.1200"/>
                    <measurement group_id="O3" value="0.274" spread="0.5011"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.025" spread="0.3427"/>
                    <measurement group_id="O2" value="-0.020" spread="0.0800"/>
                    <measurement group_id="O3" value="0.535" spread="0.8036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea</title>
        <description>Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea</title>
          <description>Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Millimoles 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: Corrected calcium, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.011" spread="0.0540"/>
                    <measurement group_id="O2" value="-0.020" spread="0.0566"/>
                    <measurement group_id="O3" value="-0.013" spread="0.0725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Corrected calcium, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.035" spread="0.0563"/>
                    <measurement group_id="O2" value="-0.070" spread="0.0424"/>
                    <measurement group_id="O3" value="-0.036" spread="0.0809"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Corrected calcium, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.003" spread="0.0483"/>
                    <measurement group_id="O2" value="-0.060" spread="0.0200"/>
                    <measurement group_id="O3" value="-0.061" spread="0.0737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Corrected calcium, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.003" spread="0.0509"/>
                    <measurement group_id="O2" value="-0.060" spread="0.0721"/>
                    <measurement group_id="O3" value="-0.069" spread="0.0827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Corrected calcium, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.023" spread="0.0362"/>
                    <measurement group_id="O2" value="-0.020" spread="0.0000"/>
                    <measurement group_id="O3" value="-0.066" spread="0.0705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Corrected calcium, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.043" spread="0.0599"/>
                    <measurement group_id="O2" value="-0.027" spread="0.0808"/>
                    <measurement group_id="O3" value="-0.049" spread="0.0689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Corrected calcium, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.026" spread="0.0746"/>
                    <measurement group_id="O2" value="0.000" spread="0.0346"/>
                    <measurement group_id="O3" value="-0.035" spread="0.0550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Corrected calcium, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.037" spread="0.0678"/>
                    <measurement group_id="O2" value="0.000" spread="0.0346"/>
                    <measurement group_id="O3" value="-0.034" spread="0.0508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Corrected calcium, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.014" spread="0.0862"/>
                    <measurement group_id="O2" value="-0.020" spread="0.0600"/>
                    <measurement group_id="O3" value="-0.020" spread="0.0629"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Urea, n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0714" spread="1.13389"/>
                    <measurement group_id="O2" value="-2.0000" spread="0.00000"/>
                    <measurement group_id="O3" value="0.3043" spread="1.56481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Urea, n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="1.13389"/>
                    <measurement group_id="O2" value="-0.7500" spread="0.35355"/>
                    <measurement group_id="O3" value="0.3043" spread="1.67698"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Urea, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4375" spread="1.08356"/>
                    <measurement group_id="O2" value="-0.8333" spread="0.28868"/>
                    <measurement group_id="O3" value="0.3182" spread="1.34116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Urea, n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1429" spread="1.14434"/>
                    <measurement group_id="O2" value="-0.8333" spread="0.76376"/>
                    <measurement group_id="O3" value="0.5682" spread="1.30289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Urea, n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1875" spread="1.30760"/>
                    <measurement group_id="O2" value="-0.5000" spread="0.50000"/>
                    <measurement group_id="O3" value="0.0952" spread="1.50515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: Urea, n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1875" spread="1.25178"/>
                    <measurement group_id="O2" value="-0.1667" spread="0.76376"/>
                    <measurement group_id="O3" value="0.4091" spread="1.40269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: Urea, n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2857" spread="1.70434"/>
                    <measurement group_id="O2" value="-0.8333" spread="0.28868"/>
                    <measurement group_id="O3" value="0.4000" spread="1.47434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: Urea, n=7,3,18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2857" spread="1.75255"/>
                    <measurement group_id="O2" value="-0.8333" spread="1.15470"/>
                    <measurement group_id="O3" value="0.0912" spread="1.52540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: Urea, n=7,3,19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0714" spread="2.11007"/>
                    <measurement group_id="O2" value="-1.0000" spread="0.50000"/>
                    <measurement group_id="O3" value="0.1510" spread="1.76450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate</title>
        <description>Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate</title>
          <description>Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Milliliter/minute/1.73 square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=7,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.4180" spread="10.28099"/>
                    <measurement group_id="O2" value="1.7630" spread="1.28693"/>
                    <measurement group_id="O3" value="-0.7528" spread="9.25789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,2,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3085" spread="8.34077"/>
                    <measurement group_id="O2" value="-2.7765" spread="9.78424"/>
                    <measurement group_id="O3" value="-1.5543" spread="9.55847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4780" spread="9.34592"/>
                    <measurement group_id="O2" value="-4.3223" spread="3.88914"/>
                    <measurement group_id="O3" value="-3.4266" spread="6.99189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3446" spread="7.12100"/>
                    <measurement group_id="O2" value="2.6893" spread="5.61068"/>
                    <measurement group_id="O3" value="-5.1256" spread="7.41957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4405" spread="12.50899"/>
                    <measurement group_id="O2" value="-0.9993" spread="5.98467"/>
                    <measurement group_id="O3" value="-2.5432" spread="7.12712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0010" spread="8.15284"/>
                    <measurement group_id="O2" value="-7.1513" spread="6.77426"/>
                    <measurement group_id="O3" value="-5.1038" spread="8.90164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7351" spread="12.23546"/>
                    <measurement group_id="O2" value="-0.2900" spread="6.19990"/>
                    <measurement group_id="O3" value="-8.5267" spread="7.71222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9239" spread="13.25672"/>
                    <measurement group_id="O2" value="-3.9510" spread="5.74000"/>
                    <measurement group_id="O3" value="-4.2795" spread="9.19612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2733" spread="15.36640"/>
                    <measurement group_id="O2" value="-7.7100" spread="8.47159"/>
                    <measurement group_id="O3" value="-2.7185" spread="8.91665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick</title>
        <description>Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented.</description>
        <time_frame>Up to Day 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick</title>
          <description>Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Potential of hydrogen, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific gravity, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria</title>
        <description>Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of &gt;=40 millimeter of mercury [mmHg]), DBP (increase or decrease from Baseline of &gt;=20 mmHg), and HR (increase or decrease from Baseline of &gt;=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment.</description>
        <time_frame>Baseline (Day 1: Pre-dose) and up to Day 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria</title>
          <description>Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of &gt;=40 millimeter of mercury [mmHg]), DBP (increase or decrease from Baseline of &gt;=20 mmHg), and HR (increase or decrease from Baseline of &gt;=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP: Decrease &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Increase &gt;=20</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Decrease &gt;=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Increase &gt;=40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HR: Decrease &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HR: Increase &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Body Temperature</title>
        <description>Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Temperature</title>
          <description>Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.037" spread="0.4689"/>
                    <measurement group_id="O2" value="0.400" spread="0.4359"/>
                    <measurement group_id="O3" value="0.117" spread="0.3833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.037" spread="0.3889"/>
                    <measurement group_id="O2" value="0.467" spread="0.6807"/>
                    <measurement group_id="O3" value="0.130" spread="0.3470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" spread="0.4121"/>
                    <measurement group_id="O2" value="0.033" spread="0.4163"/>
                    <measurement group_id="O3" value="0.039" spread="0.4197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.100" spread="0.2449"/>
                    <measurement group_id="O2" value="0.133" spread="0.3215"/>
                    <measurement group_id="O3" value="0.177" spread="0.4253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: n=8,3,21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.112" spread="0.5303"/>
                    <measurement group_id="O2" value="0.267" spread="0.5132"/>
                    <measurement group_id="O3" value="0.186" spread="0.4328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" spread="0.3563"/>
                    <measurement group_id="O2" value="0.467" spread="0.5859"/>
                    <measurement group_id="O3" value="-0.023" spread="0.3854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.257" spread="0.3505"/>
                    <measurement group_id="O2" value="0.400" spread="0.6245"/>
                    <measurement group_id="O3" value="0.100" spread="0.4952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.257" spread="0.3409"/>
                    <measurement group_id="O2" value="0.167" spread="0.5033"/>
                    <measurement group_id="O3" value="0.118" spread="0.6054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.143" spread="0.4860"/>
                    <measurement group_id="O2" value="0.267" spread="0.4933"/>
                    <measurement group_id="O3" value="0.212" spread="0.5122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings</title>
        <description>Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.</description>
        <time_frame>Up to Day 57</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings</title>
          <description>Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed.</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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal- not clinically significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal- clinically significant</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of GSK2330811</title>
        <description>Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of GSK2330811</title>
          <description>Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed.</description>
          <population>PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Nanogram 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="3"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: n=3,24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Mean and standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than [&gt;] 30 percent [%] of values were imputed).</measurement>
                    <measurement group_id="O2" value="0.0" spread="NA">Mean and standard deviation could not be calculated due to high proportion of NQ values (&gt;30% of values were imputed).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5510.7" spread="2455.19"/>
                    <measurement group_id="O2" value="16197.9" spread="6354.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7782.3" spread="1563.04"/>
                    <measurement group_id="O2" value="23407.0" spread="8830.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9868.7" spread="818.51"/>
                    <measurement group_id="O2" value="32645.7" spread="15225.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10993.0" spread="717.89"/>
                    <measurement group_id="O2" value="29254.4" spread="16911.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4123.0" spread="420.29"/>
                    <measurement group_id="O2" value="11087.1" spread="7661.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=3,16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.0" spread="408.47"/>
                    <measurement group_id="O2" value="2892.9" spread="4093.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.0" spread="NA">Mean and standard deviation could not be calculated due to high proportion of NQ values (&gt;30% of values were imputed).</measurement>
                    <measurement group_id="O2" value="729.2" spread="841.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811</title>
        <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>PK Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811</title>
          <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811.</description>
          <population>PK Population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Nanogram 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="3"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10993.0" spread="717.89"/>
                    <measurement group_id="O2" value="29254.4" spread="16911.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL/F) of GSK2330811</title>
        <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>PK Population. Only those participants with data available at the specified time points were analyzed. CL/F was estimated based on population PK modelling on the combination of data of participants dosed with GSK2330811, as it was more appropriate due to limited dose range (100 mg and 300 mg).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2330811 100 mg and GSK2330811 300 mg - Overall</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 mg and 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL/F) of GSK2330811</title>
          <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
          <population>PK Population. Only those participants with data available at the specified time points were analyzed. CL/F was estimated based on population PK modelling on the combination of data of participants dosed with GSK2330811, as it was more appropriate due to limited dose range (100 mg and 300 mg).</population>
          <units>Liter per hour</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0147" lower_limit="0.0132" upper_limit="0.0163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution (Vss/F) of GSK2330811</title>
        <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>PK Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2330811 100 mg and GSK2330811 300 mg - Overall</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 mg and 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vss/F) of GSK2330811</title>
          <description>Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.</description>
          <population>PK Population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Liter</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" lower_limit="NA" upper_limit="NA">The PK parameters were calculated by fitting a population PK model using the combined data of participants dosed with 100 mg and 300 mg of GSK2330811. Since a minimal model was utilized, the Vss/F value was fixed to a plasma physiological value obtained from the literature. Hence, a confidence interval cannot be provided for this parameter.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Level of Total Oncostatin M (OSM)</title>
        <description>Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Level of Total Oncostatin M (OSM)</title>
          <description>Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.110" lower_limit="13.08" upper_limit="57.40"/>
                    <measurement group_id="O2" value="30.590" lower_limit="6.19" upper_limit="38.71"/>
                    <measurement group_id="O3" value="27.455" lower_limit="16.93" upper_limit="81.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.175" lower_limit="18.07" upper_limit="57.48"/>
                    <measurement group_id="O2" value="576.850" lower_limit="417.28" upper_limit="696.18"/>
                    <measurement group_id="O3" value="721.020" lower_limit="496.63" upper_limit="1482.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.210" lower_limit="12.84" upper_limit="48.82"/>
                    <measurement group_id="O2" value="499.540" lower_limit="487.14" upper_limit="635.94"/>
                    <measurement group_id="O3" value="974.220" lower_limit="398.94" upper_limit="2500.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.700" lower_limit="13.40" upper_limit="43.94"/>
                    <measurement group_id="O2" value="651.710" lower_limit="554.93" upper_limit="971.25"/>
                    <measurement group_id="O3" value="1211.570" lower_limit="636.83" upper_limit="2350.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.275" lower_limit="14.38" upper_limit="66.28"/>
                    <measurement group_id="O2" value="613.290" lower_limit="555.09" upper_limit="1229.71"/>
                    <measurement group_id="O3" value="1357.645" lower_limit="542.85" upper_limit="2500.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.350" lower_limit="8.42" upper_limit="81.11"/>
                    <measurement group_id="O2" value="687.810" lower_limit="419.04" upper_limit="935.76"/>
                    <measurement group_id="O3" value="1044.650" lower_limit="186.06" upper_limit="2378.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.850" lower_limit="13.13" upper_limit="43.07"/>
                    <measurement group_id="O2" value="206.900" lower_limit="143.55" upper_limit="363.62"/>
                    <measurement group_id="O3" value="359.340" lower_limit="58.13" upper_limit="1097.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.800" lower_limit="19.58" upper_limit="36.13"/>
                    <measurement group_id="O2" value="54.290" lower_limit="40.96" upper_limit="137.88"/>
                    <measurement group_id="O3" value="142.830" lower_limit="28.82" upper_limit="607.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Level of Free OSM</title>
        <description>Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum.</description>
        <time_frame>Days 1, 15, 29, 57, 85, 113, 155 and 197</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Level of Free OSM</title>
          <description>Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
          <units>Picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.72" lower_limit="8.3" upper_limit="45.3"/>
                    <measurement group_id="O2" value="28.93" lower_limit="4.5" upper_limit="36.8"/>
                    <measurement group_id="O3" value="20.74" lower_limit="8.8" upper_limit="56.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.85" lower_limit="11.7" upper_limit="40.7"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.35" lower_limit="4.5" upper_limit="37.1"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.62" lower_limit="6.1" upper_limit="35.9"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.37" lower_limit="5.9" upper_limit="47.6"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113: n=7,3,20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.78" lower_limit="5.7" upper_limit="58.5"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 155: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.54" lower_limit="7.3" upper_limit="32.7"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.7" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.43" lower_limit="12.2" upper_limit="23.5"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.73" upper_limit="0.73"/>
                    <measurement group_id="O3" value="0.73" lower_limit="0.7" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-GSK2330811 Antibodies</title>
        <description>Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'.</description>
        <time_frame>Days 1, 15, 57, 85 and 197</time_frame>
        <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O2">
            <title>GSK2330811 100 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
          <group group_id="O3">
            <title>GSK2330811 300 mg</title>
            <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-GSK2330811 Antibodies</title>
          <description>Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'.</description>
          <population>Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in 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="8"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </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="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: n=8,3,23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="23"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: n=7,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: n=8,3,22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="22"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197: n=7,3,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="17"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality, SAEs and non-SAEs were collected up to Day 197. The protocol allowed for additional SAEs to be collected after Day 197; collected up to Day 603 post first dose</time_frame>
      <desc>Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="E2">
          <title>GSK2330811 100 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
        <group group_id="E3">
          <title>GSK2330811 300 mg</title>
          <description>Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="6" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial overgrowth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Electrocardiogram PR prolongation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Reticulocyte count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Reticulocyte percentage increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </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="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="24"/>
              </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="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic elastosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lentigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lipoatrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Raynaud's phenomenon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </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/NCT03041025
org study id: 201247
secondary id: 2016-003417-95
nct id: NCT03041025
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis
      (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no
      approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811
      has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with
      fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,
      randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be
      the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female
      participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a
      disease duration of <= 60 months will be enrolled. Approximately 24 to 40 participants will
      be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted
      to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is
      planned to consist of at least 4 participants, randomized such that 3 participants will
      receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to
      consist of at least 20 participants, randomized such that participants will receive
      GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to
      34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and
      follow-up period of 16 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
time frame: Up to Day 197, but protocol allowed for additional events to be collected; up to Day 603 post first dose
description: An adverse event (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. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.
measure: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameter: Hematocrit
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH)
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV)
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW)
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Reticulocyte Production Index
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent [%]) multiply by (x) (hematocrit [%] divided by [/] 45) x 1/ reticulocyte maturation time'.
measure: Change From Baseline Hematology Parameter: Reticulocytes
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
time frame: Up to Day 197
description: Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: <30 grams per liter (g/L) (albumin), high: >44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: <3 or high: >9 mmol/L (glucose), low: <3 or high: >5.5 mmol/L (potassium), and low: <130 or high: >150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was 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 within 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 up to 100%.
measure: Change From Baseline in Chemistry Parameter: Total Protein
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH)
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides
time frame: Baseline (Day 1: Pre-dose) and Day 85
description: Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value.
measure: Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick
time frame: Up to Day 197
description: Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented.
measure: Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria
time frame: Baseline (Day 1: Pre-dose) and up to Day 197
description: Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of >=40 millimeter of mercury [mmHg]), DBP (increase or decrease from Baseline of >=20 mmHg), and HR (increase or decrease from Baseline of >=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment.
measure: Change From Baseline in Body Temperature
time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
description: Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
measure: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
time frame: Up to Day 57
description: Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
measure: Plasma Concentrations of GSK2330811
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed.
measure: Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at the indicated time points for PK analysis of GSK2330811.
measure: Apparent Clearance (CL/F) of GSK2330811
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.
measure: Apparent Volume of Distribution (Vss/F) of GSK2330811
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.
measure: Serum Level of Total Oncostatin M (OSM)
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol.
measure: Serum Level of Free OSM
time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
description: Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum.
measure: Number of Participants With Positive Anti-GSK2330811 Antibodies
time frame: Days 1, 15, 57, 85 and 197
description: Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'.
arm group label: Cohort 1: GSK2330811 100 mg
arm group type: Experimental
description: During Cohort 1, participants will receive a single dose of GSK2330811 100 mg by SC injection via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.
arm group label: Cohort 2: GSK2330811 300 mg
arm group type: Experimental
description: During Cohort 2, participants will receive a single dose of GSK2330811 300 mg by SC injection (3 vials of 1 mL each of GSK2330811 100 mg) via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.
arm group label: Cohort 1: Placebo
arm group type: Placebo Comparator
description: During Cohort 1, participants will receive a single dose of placebo by SC injection via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.
arm group label: Cohort 2: Placebo
arm group type: Placebo Comparator
description: During Cohort 2, participants will receive a single dose of placebo by SC injection (3 vials of 1 mL each) via needle and syringe in to the abdomen, thigh or upper arm by the investigator or designee at every other week from D1 to D71 (total 6 doses) for 10 weeks. Participants will be followed-up up to W28 D197.
intervention type: Drug
intervention name: GSK2330811
description: GSK2330811 will be provided in vials and packed in 1 vial per carton. Each vial will contain 1.2 mL fill with 1 mL extractable volume at 100 mg/mL.
arm group label: Cohort 1: GSK2330811 100 mg
arm group label: Cohort 2: GSK2330811 300 mg
intervention type: Drug
intervention name: Placebo
description: Normal saline (0.9 percent weight per volume sodium chloride).
arm group label: Cohort 1: Placebo
arm group label: Cohort 2: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Netherlands
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
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 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: 