<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/NCT03261167</url>
  </required_header>
  <id_info>
    <org_study_id>207660</org_study_id>
    <nct_id>NCT03261167</nct_id>
  </id_info>
  <brief_title>A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity</brief_title>
  <official_title>A Phase III Study (a Placebo Controlled, Randomized, Double-blind Comparative Study and an Open-label, Uncontrolled Study) to Evaluate the Efficacy and Safety of GSK1358820 in Patients With Post-stroke Upper Limb Spasticity</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In&#xD;
      Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for&#xD;
      upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400&#xD;
      units of botulinum toxin A which can help to increase the maximum dose per administration to&#xD;
      400 units from 240 units as the treatment with 240 units is considered insufficient in&#xD;
      subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be&#xD;
      randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase&#xD;
      followed by open-label phase in which 400 units of the study treatment will be injected in&#xD;
      both the groups. The study period will be up to 52 weeks, consisting of a screening phase up&#xD;
      to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase&#xD;
      (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Subjects will receive either 400 units of botulinum toxin A injection or 240 units of botulinum toxin A injection plus placebo in double blind phase. Eligible subjects for open-label treatment period will receive 400 units of botulinum toxin A injection.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This study will contain a double blind treatment period (Part 1) followed by open-label treatment period (Part 2/Part3/Part4).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6</measure>
    <time_frame>Week 6</time_frame>
    <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12</measure>
    <time_frame>Week 2, Week 4, Week 6 and Week 12</time_frame>
    <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])</measure>
    <time_frame>Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12</time_frame>
    <description>The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12</measure>
    <time_frame>Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12</time_frame>
    <description>The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment</measure>
    <time_frame>Up to 84 days post first treatment</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs and SAEs-Overall Study Period</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Findings After Physical Examinations</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48</measure>
    <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
    <description>Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48</measure>
    <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
    <description>Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48</measure>
    <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
    <description>Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Spasticity, Post-Stroke</condition>
  <arm_group>
    <arm_group_label>Part 1: Subjects receiving 400 units of botulinum toxin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a total dose of 400 units of botulinum toxin A of which 240 units will be injected into the muscles that act on finger (including thumb flexors) and wrist flexors, and a total of 160 units will be injected into the muscles that act on the elbow flexors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Subjects receiving 240 units of botulinum toxin A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive 240 units of botulinum toxin A injected into the muscles that act on the finger (including thumb flexors) and wrist flexors. Placebo will be injected into the muscles that act on the elbow flexors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2,3,4: Subjects receiving 400 units of botulinum toxin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive botulinum toxin A with a dose of 400 units injected in a divided doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin A (GSK1358820)</intervention_name>
    <description>GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.</description>
    <arm_group_label>Part 1: Subjects receiving 240 units of botulinum toxin A</arm_group_label>
    <arm_group_label>Part 1: Subjects receiving 400 units of botulinum toxin A</arm_group_label>
    <arm_group_label>Part 2,3,4: Subjects receiving 400 units of botulinum toxin A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo injection will contain sodium chloride (0.9 mg).</description>
    <arm_group_label>Part 1: Subjects receiving 240 units of botulinum toxin A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For screening phase (Day -28 to Day -1): Between 20 and 80 years of age at the time of&#xD;
             informed consent (ICF).&#xD;
&#xD;
          -  Subjects with at least a 3-month history of upper limb spasticity after the most&#xD;
             recent stroke.&#xD;
&#xD;
          -  Subjects who have spastic symptoms in the finger (including the thumb), wrist, and&#xD;
             elbow flexors whom the investigator considers the injections of 400 units of the&#xD;
             product is necessary for the upper limb based on the muscle spasms and the symptoms of&#xD;
             the subject.&#xD;
&#xD;
          -  Subjects who have a previous treatment history of 240 units of the product for the&#xD;
             upper limb at least 16 weeks before screening.&#xD;
&#xD;
          -  Subjects who meet following criteria on MAS at screening (Test position : sitting): at&#xD;
             least 3 in for the elbow flexors and at least 2 in the finger or wrist flexors.&#xD;
&#xD;
          -  Subjects who have severe upper limb spasticity, which deserves to be treated with 400&#xD;
             units of the product in the divided dose and was previously injected 240 units of the&#xD;
             product.&#xD;
&#xD;
          -  Subjects whom the investigator considers that enrolment in the study poses no problems&#xD;
             based on the laboratory data results at screening.&#xD;
&#xD;
          -  Subjects who are free from a history of acute decreased lung function (hospitalization&#xD;
             with aggravated asthma/ chronic obstructive pulmonary disease (COPD), pneumonia, or&#xD;
             signs of pneumonia, or abnormal reactive airway diseases suggested on X-rays) within&#xD;
             the last 3 months at screening and have stable pulmonary function (oxygen saturation&#xD;
             [SpO2]value is &gt;=95%).&#xD;
&#xD;
          -  Body weight &gt;=40 kilograms (kg) at screening.&#xD;
&#xD;
          -  Male or female subjects will be included. Male subjects must content to use highly&#xD;
             effective contraceptive methods and sperm donation must be avoided. Female subjects&#xD;
             who are not pregnant or lactating are considered eligible if at least one of the&#xD;
             following criteria is met; non-childbearing potential, women of childbearing potential&#xD;
             who content to follow the guidance about contraception during the study period and at&#xD;
             least for 3 months after the last dose of the product, no plan of pregnancy during the&#xD;
             study period.&#xD;
&#xD;
          -  Subjects who have ability to sign their name on the ICF.&#xD;
&#xD;
          -  For enrolment in the study (Day 1 [prior to injection]):Subjects who meet the&#xD;
             following criteria on MAS score: (Test position : sitting): At least 3 in the elbow&#xD;
             flexors and at least 2 in the finger or wrist flexors.&#xD;
&#xD;
          -  If centrally acting muscle relaxants, tetracycline antibiotics, anticholinergics,&#xD;
             benzodiazepines, or benzamides are given, the dose and regimen must be stable at least&#xD;
             for the last 2 months before Day 1; Subjects who can maintain the same dosage and&#xD;
             regimens at least in the blind phase after initial injection (dose reductions and&#xD;
             discontinuation of the drugs are acceptable in the open-label phase. However, second&#xD;
             dose increase, resumption, and or new treatment will not be performed).&#xD;
&#xD;
          -  If intrathecal baclofen is given, the dose and regimen must be stable at least for the&#xD;
             last 1 month before Day 1; Subjects who can maintain the same dosage and regimens at&#xD;
             least in the blind phase after initial injection (intravenous bolus is not acceptable,&#xD;
             dose reductions and discontinuation of the drugs are acceptable. However, second dose&#xD;
             increase, resumption, and or new treatment will not be performed).&#xD;
&#xD;
          -  If antiepileptic agents are given, the dose and regimen must be stable at least for&#xD;
             the 1 month before Day 1; Subjects who can maintain the same dose and regimens at&#xD;
             least in the blind phase after initial injection (dose reductions and discontinuation&#xD;
             of the drugs are acceptable in the open-label phase. However, second dose increase,&#xD;
             resumption, and new treatment will not be performed).&#xD;
&#xD;
          -  If a physical therapy, occupational therapy, or a static splint on the study&#xD;
             involvement upper limbs is given, the frequency and treatment regimen must be stable&#xD;
             at least for the last 3 weeks before Day 1; Subjects who can maintain the same dose&#xD;
             and regimens at least in blind phase (In the open-label phase, the frequency and&#xD;
             treatment regimen can be changed depending on the condition of spasticity).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For screening phase (Day -28 to Day -1): Subjects present with spasticity requiring&#xD;
             treatment in the non-paralytic side of the upper limb.&#xD;
&#xD;
          -  Subjects who have fixed contracture in the finger (upper limb), wrist, elbow or&#xD;
             shoulder muscle, which will be involved in the study.&#xD;
&#xD;
          -  Subjects who have medically significant capsulitis or subluxation in any one of the&#xD;
             fingers (upper limb), wrist, elbow and shoulder, which will be involved in the study,&#xD;
             or whom a investigator considers the complicated local signs of pain may affect the&#xD;
             efficacy evaluation.&#xD;
&#xD;
          -  Subjects's upper limb spasticity is attributed to other than stroke (traumatic brain&#xD;
             injury, spinal cord injury, multiple sclerosis, or cerebral palsy).&#xD;
&#xD;
          -  Subjects who have a 2-fold higher alanine aminotransferase (ALT) level than the upper&#xD;
             limit of normal (ULN).&#xD;
&#xD;
          -  Subjects who have a 1.5-fold higher bilirubin than the ULN (If a bilirubin&#xD;
             fractionation shows direct bilirubin &lt; 35%, a 1.5-fold higher free bilirubin than the&#xD;
             ULN is acceptable).&#xD;
&#xD;
          -  Subjects whom the investigator considers presence of a current medical history of&#xD;
             unstable liver diseases or biliary tract diseases (the condition will be defined by&#xD;
             development of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or&#xD;
             gastric varices, persistent jaundice or hepatic cirrhosis).&#xD;
&#xD;
          -  Subjects with corrected QT interval (QTc) &gt; 450 milliseconds (msec) or QTc &gt; 480 msec&#xD;
             in subjects with bundle branch block.&#xD;
&#xD;
          -  Subjects who use peripherally acting muscle relaxants (dantrolene sodium,&#xD;
             suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide,&#xD;
             etc.) within 1 week of screening.&#xD;
&#xD;
          -  Subjects who use antibiotic agents with neuromuscular junction inhibitory effects:&#xD;
             Aminoglycoside antibiotic agents (streptomycin sulfate, kanamycin sulfate, gentamicin&#xD;
             sulfate, neomycin sulfate, spectinomycin hydrochloride, etc.), polypeptides (polymyxin&#xD;
             B sulfate), lincomycins (lincomycin hydrochloride, clindamycin), and enviomycin&#xD;
             sulfate within 1 week of screening.&#xD;
&#xD;
          -  Subjects who was diagnosed as having a malignant tumor, or have a history of a&#xD;
             malignant tumor within the last 5 years (except completely resected basal cell&#xD;
             carcinoma or planocellular carcinoma at least 12 weeks before screening).&#xD;
&#xD;
          -  Subjects who have participated in another study of an investigational product or other&#xD;
             medical research (a clinical study of pharmacotherapy, non-pharmacotherapy, or&#xD;
             interventional device) within 30 days before screening, or are currently participating&#xD;
             in a study.&#xD;
&#xD;
          -  Subjects who are concerned likely to have an increased risk for an underlying medical&#xD;
             condition/neurological disease due to exposure of the product; subjects who have&#xD;
             myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or a serious&#xD;
             disease and use of a concomitant drug which may inhibit neuromuscular function.&#xD;
&#xD;
          -  Subjects with antihuman immunodeficiency virus (HIV) antibody positive.&#xD;
&#xD;
          -  Subjects who previously experienced allergic reactions or hypersensitivity due to&#xD;
             botulinum toxin type A, an additive agent of sodium chloride, or human serum albumin.&#xD;
&#xD;
          -  Subjects who were previously suspected to have neutralizing antibody production by a&#xD;
             investigator during an injection of botulinum toxin type A.&#xD;
&#xD;
          -  Subjects who have a skin disease such as infection at the site to be injected.&#xD;
&#xD;
          -  Subjects who suffer from serious and unstable disease, which could pose problems for&#xD;
             the safety of subjects and study procedure compliance.&#xD;
&#xD;
          -  For enrolment in the study (Day 1 [prior to injection]): Subjects who have aspiration&#xD;
             pneumonia, relapse of lower respiratory tract infection, uncontrollable asthma,&#xD;
             uncontrollable COPD, and/or underlying or a history of serious respiratory&#xD;
             dysfunction, which were clinically considered to be respiratory function impairment by&#xD;
             a investigator within 12 months before Day 1 visit.&#xD;
&#xD;
          -  Subjects who have a history of aspiration, or an underlying and/or a history of the&#xD;
             symptoms that suggests high risks for aspiration by a investigator within 12 months&#xD;
             before Day 1 (serious salivation requiring changing in a type of diet, chronic&#xD;
             dysphagia that is difficult to swallow).&#xD;
&#xD;
          -  Subjects who were treated with botulinum toxin for spasticity of upper limb less than&#xD;
             16 weeks before Day 1 visit.&#xD;
&#xD;
          -  Subjects who underwent surgical interventions, phenol block, ethanol block or muscle&#xD;
             afferent block (MAB) within 12 months before Day 1 visit, or these interventions are&#xD;
             planned during the study period in any one of the finger (upper limb), wrist, elbow or&#xD;
             shoulder muscles, which will be involved in the study.&#xD;
&#xD;
          -  Subjects who placed a surgical cast or a dynamic splint within 3 months before Day 1&#xD;
             study visit, and/or these interventions are planned to be placed on the upper limb to&#xD;
             be involved in the study.&#xD;
&#xD;
          -  Subjects who were injected corticosteroid or an anesthetic agent into the finger&#xD;
             (upper limb), wrist, or shoulder flexors, which will be involved in the study within 3&#xD;
             months before Day 1 visit, or these injections are planned during the study.&#xD;
&#xD;
          -  Subjects who received constraint-induced movement therapy (CIMT) within 3 months&#xD;
             before Day 1 visit or CIMT is planned during the blind phase.&#xD;
&#xD;
          -  Subjects who underwent ultrasound therapy, transcutaneous electrical nerve stimulation&#xD;
             (TENS) , electrical stimulation therapy, or acupuncture therapy in the upper arm,&#xD;
             which will be involved in the study within 1 month before Day 1 visit, or these&#xD;
             therapies are planned during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>465-8620</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>490-1405</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>277-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>279-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukui</city>
        <zip>910-0067</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>819-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>720-0825</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>005-0802</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hyogo</city>
        <zip>651-2181</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>300-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>312-0057</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-0067</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>227-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>245-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>259-1143</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kochi</city>
        <zip>780-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-0924</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>399-6461</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Niigata</city>
        <zip>945-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oita</city>
        <zip>870-0862</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Okayama</city>
        <zip>703-8265</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>538-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>570-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>580-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saga</city>
        <zip>849-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>417-0801</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>433-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokushima</city>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>102-8798</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>123-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>165-8906</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>192-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>201-8601</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wakayama</city>
        <zip>641-8509</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yamagata</city>
        <zip>992-0057</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Abo M, Shigematsu T, Hara H, Matsuda Y, Nimura A, Yamashita Y, Takahashi K. Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase. Toxins (Basel). 2020 Feb 18;12(2):127. doi: 10.3390/toxins12020127.</citation>
    <PMID>32085529</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>February 27, 2019</results_first_submitted>
  <results_first_submitted_qc>September 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2019</results_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Botulinum toxin A</keyword>
  <keyword>Safety</keyword>
  <keyword>post-stroke upper limb spasticity</keyword>
  <keyword>Efficacy</keyword>
  <keyword>GSK1358820</keyword>
  <keyword>double blind</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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 is available via the Clinical Study Data Request site (click on the link provided below)</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>https://clinicalstudydatarequest.com/Posting.aspx?ID=20343</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 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03261167/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>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03261167/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multicenter study conducted at 40 study centers in Japan, of which 38 centers enrolled participants.</recruitment_details>
      <pre_assignment_details>A total of 131 participants were screened of which 7 participants were screen failures [reason being did not meet inclusion exclusion criteria (6) and withdrew consent (1)] and finally 124 participants were randomized (63 participants in the GSK1358820 240 units [U] group and 61 participants in the GSK1358820 400 U group).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK1358820 240 U</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
        </group>
        <group group_id="P2">
          <title>GSK1358820 400 U</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind(Treatment cyc1,Upto Week48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </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="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label(Treatment cycle2,Upto Week48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol defined stopping criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label(Treatment cycle3,Upto Week48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label(Treatment cycle4,Upto Week48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK1358820 240 U</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
        </group>
        <group group_id="B2">
          <title>GSK1358820 400 U</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
        </group>
        <group group_id="B3">
          <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="63"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="124"/>
          </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="57.3" spread="10.98"/>
                    <measurement group_id="B2" value="57.1" spread="9.90"/>
                    <measurement group_id="B3" value="57.2" spread="10.42"/>
                  </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="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="99"/>
                  </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>
              <title>Japanese/East Asian Heritage (AH)/South East AH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian &amp; Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6</title>
        <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.</description>
        <time_frame>Week 6</time_frame>
        <population>Intent to treat 1 (ITT1) Population comprised of participants who were randomized in the study and who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6</title>
          <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.</description>
          <population>Intent to treat 1 (ITT1) Population comprised of participants who were randomized in the study and who had at least 1 post-baseline efficacy assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.8"/>
                    <measurement group_id="O2" value="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference</param_type>
            <param_value>18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>35.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12</title>
        <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.</description>
        <time_frame>Week 2, Week 4, Week 6 and Week 12</time_frame>
        <population>ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12</title>
          <description>MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.</description>
          <population>ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Elbow Flexion, Week 2, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 4, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4"/>
                    <measurement group_id="O2" value="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 6, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.8"/>
                    <measurement group_id="O2" value="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 12, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 2, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8"/>
                    <measurement group_id="O2" value="72.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 4, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5"/>
                    <measurement group_id="O2" value="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 6, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.0"/>
                    <measurement group_id="O2" value="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist flexion, Week 12, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.0"/>
                    <measurement group_id="O2" value="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 2, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3"/>
                    <measurement group_id="O2" value="78.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 4, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                    <measurement group_id="O2" value="75.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 6, n=63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.0"/>
                    <measurement group_id="O2" value="72.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 12, n =63,61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.0"/>
                    <measurement group_id="O2" value="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 2, n=60,54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 4, n=60,54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7"/>
                    <measurement group_id="O2" value="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 6, n=60,54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb flexion, Week 12,n=60,54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>33.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.0</ci_lower_limit>
            <ci_upper_limit>49.2</ci_upper_limit>
            <estimate_desc>Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>21.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.9</ci_lower_limit>
            <ci_upper_limit>38.5</ci_upper_limit>
            <estimate_desc>Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>18.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>35.5</ci_upper_limit>
            <estimate_desc>Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>30.1</ci_upper_limit>
            <estimate_desc>Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-5.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.9</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.0</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
            <estimate_desc>Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-12.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.5</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
            <estimate_desc>Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-9.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.2</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
            <estimate_desc>Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.9</ci_lower_limit>
            <ci_upper_limit>4.7</ci_upper_limit>
            <estimate_desc>Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-10.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.3</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
            <estimate_desc>Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-8.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.8</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
            <estimate_desc>Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.7</ci_lower_limit>
            <ci_upper_limit>17.4</ci_upper_limit>
            <estimate_desc>Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-9.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.4</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
            <estimate_desc>Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-6.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.6</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
            <estimate_desc>Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>15.7</ci_upper_limit>
            <estimate_desc>Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted rate difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>17.9</ci_upper_limit>
            <estimate_desc>Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])</title>
        <description>The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12</time_frame>
        <population>ITT1 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>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])</title>
          <description>The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
          <population>ITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Elbow Flexion, Week 2, n=63,60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.59" spread="0.089"/>
                    <measurement group_id="O2" value="-1.07" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 4, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.097"/>
                    <measurement group_id="O2" value="-1.12" spread="0.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 6, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="0.107"/>
                    <measurement group_id="O2" value="-1.09" spread="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion, Week 12, n=60,57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.072"/>
                    <measurement group_id="O2" value="-0.61" spread="0.101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 2, n=63,60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="0.120"/>
                    <measurement group_id="O2" value="-1.21" spread="0.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 4, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.45" spread="0.122"/>
                    <measurement group_id="O2" value="-1.35" spread="0.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist Flexion, Week 6, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="0.115"/>
                    <measurement group_id="O2" value="-1.31" spread="0.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wrist flexion, Week 12, n=60,57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.097"/>
                    <measurement group_id="O2" value="-0.59" spread="0.107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 2, n=63,60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.38" spread="0.113"/>
                    <measurement group_id="O2" value="-1.28" spread="0.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 4, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.49" spread="0.117"/>
                    <measurement group_id="O2" value="-1.32" spread="0.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 6, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.36" spread="0.118"/>
                    <measurement group_id="O2" value="-1.22" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finger Flexion, Week 12, n=60,57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.63" spread="0.116"/>
                    <measurement group_id="O2" value="-0.59" spread="0.097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 2, n=60,53</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.24" spread="0.123"/>
                    <measurement group_id="O2" value="-0.96" spread="0.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 4, n=60,53</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="0.127"/>
                    <measurement group_id="O2" value="-1.15" spread="0.138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb Flexion, Week 6, n=60,53</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" spread="0.119"/>
                    <measurement group_id="O2" value="-1.10" spread="0.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thumb flexion, Week 12, n=57,51</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.133"/>
                    <measurement group_id="O2" value="-0.61" spread="0.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.22</ci_upper_limit>
            <estimate_desc>Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
            <estimate_desc>Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
            <estimate_desc>Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.27</ci_lower_limit>
            <ci_upper_limit>0.42</ci_upper_limit>
            <estimate_desc>Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
            <estimate_desc>Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
            <estimate_desc>Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
            <estimate_desc>Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>0.43</ci_upper_limit>
            <estimate_desc>Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
            <estimate_desc>Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
            <estimate_desc>Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
            <estimate_desc>Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
            <estimate_desc>Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
            <estimate_desc>Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
            <estimate_desc>Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12</title>
        <description>The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12</time_frame>
        <population>ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12</title>
          <description>The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.</description>
          <population>ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>Scores on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2, n=63,60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.34" spread="0.087"/>
                    <measurement group_id="O2" value="-0.59" spread="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.096"/>
                    <measurement group_id="O2" value="-0.62" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6, n=63,59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="0.081"/>
                    <measurement group_id="O2" value="-0.67" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=60,57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.082"/>
                    <measurement group_id="O2" value="-0.63" spread="0.092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
            <estimate_desc>Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
            <estimate_desc>Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
            <estimate_desc>Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.52</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
            <estimate_desc>Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment</title>
        <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
        <time_frame>Up to 84 days post first treatment</time_frame>
        <population>Safety1 Population. Safety1 Population comprised of all participants who were randomized in the study and who receive study treatment at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment</title>
          <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
          <population>Safety1 Population. Safety1 Population comprised of all participants who were randomized in the study and who receive study treatment at least once.</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="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AEs and SAEs-Overall Study Period</title>
        <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs and SAEs-Overall Study Period</title>
          <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.</description>
          <population>Safety1 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="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Findings After Physical Examinations</title>
        <description>Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety1 Population. This analysis was not planned and data was not collected and captured in the database.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Findings After Physical Examinations</title>
          <description>Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.</description>
          <population>Safety1 Population. This analysis was not planned and data was not collected and captured in the database.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline</title>
        <description>Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety1 Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline</title>
          <description>Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
          <population>Safety1 Population. Only those participants with data available at the indicated 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="62"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eosinophils, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean corpuscle hemoglobin, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean corpuscle hemoglobin, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean corpuscle volume, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean corpuscle volume, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total neutrophils, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total neutrophils, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cell count, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cell count, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell count, To low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell count, To high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline</title>
        <description>Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline</title>
          <description>Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.</description>
          <population>Safety 1 Population. Only those participants with data available at the indicated 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="62"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alkaline Phosphatase, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine amino transferase, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate amino transferase, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct bilirubin, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total bilirubin, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total protein, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total protein, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis</title>
        <description>Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis</title>
          <description>Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.</description>
          <population>Safety 1 Population. Only those participants with data available at the indicated 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="61"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Occult blood, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood, Increase to trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood, Increase to 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood, Increase to 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult blood, Increase to 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Any increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Increase to trace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Increase to 1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Increase to 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Increase to 3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Increase to 4+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48</title>
        <description>Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
        <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48</title>
          <description>Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
          <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, Week 12; n=60, 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="11.29"/>
                    <measurement group_id="O2" value="1.3" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 12; n=60, 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="8.01"/>
                    <measurement group_id="O2" value="0.1" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 48; n=57, 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="13.85"/>
                    <measurement group_id="O2" value="-1.7" spread="14.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 48; n=57, 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="10.01"/>
                    <measurement group_id="O2" value="-1.2" spread="11.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48</title>
        <description>Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
        <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48</title>
          <description>Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
          <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12; n=60, 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="9.95"/>
                    <measurement group_id="O2" value="2.6" spread="8.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n=57, 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="10.05"/>
                    <measurement group_id="O2" value="-0.1" spread="9.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48</title>
        <description>Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1), Week 12 and Week 48</time_frame>
        <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1358820 240 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
          <group group_id="O2">
            <title>GSK1358820 400 U</title>
            <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48</title>
          <description>Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.</description>
          <population>Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).</population>
          <units>Degree 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="63"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12; n=59, 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.428"/>
                    <measurement group_id="O2" value="-0.08" spread="0.466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n=57, 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.505"/>
                    <measurement group_id="O2" value="-0.06" spread="0.461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase.</time_frame>
      <desc>Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK1358820 240 U (Double Blind-Treatment Cycle 1)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.</description>
        </group>
        <group group_id="E2">
          <title>GSK1358820 400 U (Double Blind-Treatment Cycle 1)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.</description>
        </group>
        <group group_id="E3">
          <title>GSK1358820 240 U (Open Label-Treatment Cycle 2)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).</description>
        </group>
        <group group_id="E4">
          <title>GSK1358820 400 U (Open labelTreatment Cycle 2)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).</description>
        </group>
        <group group_id="E5">
          <title>GSK1358820 240 U (Open Label-Treatment Cycle 3)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments.</description>
        </group>
        <group group_id="E6">
          <title>GSK1358820 400 U (Open Label-Treatment Cycle 3)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments.</description>
        </group>
        <group group_id="E7">
          <title>GSK1358820 240 U (Open Label-Treatment Cycle 4)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.</description>
        </group>
        <group group_id="E8">
          <title>GSK1358820 400 U (Open Label-Treatment Cycle 4)</title>
          <description>Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</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="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased activity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="19" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="13" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="40"/>
              </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/NCT03261167
org study id: 207660
nct id: NCT03261167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In
      Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for
      upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400
      units of botulinum toxin A which can help to increase the maximum dose per administration to
      400 units from 240 units as the treatment with 240 units is considered insufficient in
      subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be
      randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase
      followed by open-label phase in which 400 units of the study treatment will be injected in
      both the groups. The study period will be up to 52 weeks, consisting of a screening phase up
      to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase
      (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will receive either 400 units of botulinum toxin A injection or 240 units of botulinum toxin A injection plus placebo in double blind phase. Eligible subjects for open-label treatment period will receive 400 units of botulinum toxin A injection.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This study will contain a double blind treatment period (Part 1) followed by open-label treatment period (Part 2/Part3/Part4).
measure: Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6
time frame: Week 6
description: MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.
measure: Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12
time frame: Week 2, Week 4, Week 6 and Week 12
description: MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.
measure: Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])
time frame: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12
description: The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12
time frame: Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12
description: The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment
time frame: Up to 84 days post first treatment
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
measure: Number of Participants With AEs and SAEs-Overall Study Period
time frame: Up to Week 48
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
measure: Number of Participants With Abnormal Findings After Physical Examinations
time frame: Up to Week 48
description: Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.
measure: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
time frame: Up to Week 48
description: Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
measure: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
time frame: Up to Week 48
description: Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
measure: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis
time frame: Up to Week 48
description: Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
measure: Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48
time frame: Baseline (Day 1), Week 12 and Week 48
description: Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48
time frame: Baseline (Day 1), Week 12 and Week 48
description: Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48
time frame: Baseline (Day 1), Week 12 and Week 48
description: Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
arm group label: Part 1: Subjects receiving 400 units of botulinum toxin A
arm group type: Experimental
description: Subjects will receive a total dose of 400 units of botulinum toxin A of which 240 units will be injected into the muscles that act on finger (including thumb flexors) and wrist flexors, and a total of 160 units will be injected into the muscles that act on the elbow flexors.
arm group label: Part 1: Subjects receiving 240 units of botulinum toxin A
arm group type: Active Comparator
description: Subjects will receive 240 units of botulinum toxin A injected into the muscles that act on the finger (including thumb flexors) and wrist flexors. Placebo will be injected into the muscles that act on the elbow flexors.
arm group label: Part 2,3,4: Subjects receiving 400 units of botulinum toxin A
arm group type: Experimental
description: Subjects will receive botulinum toxin A with a dose of 400 units injected in a divided doses.
intervention type: Drug
intervention name: Botulinum toxin A (GSK1358820)
description: GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.
arm group label: Part 1: Subjects receiving 240 units of botulinum toxin A
arm group label: Part 1: Subjects receiving 400 units of botulinum toxin A
arm group label: Part 2,3,4: Subjects receiving 400 units of botulinum toxin A
intervention type: Drug
intervention name: Placebo
description: Placebo injection will contain sodium chloride (0.9 mg).
arm group label: Part 1: Subjects receiving 240 units of botulinum toxin A
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Japan
citation: Abo M, Shigematsu T, Hara H, Matsuda Y, Nimura A, Yamashita Y, Takahashi K. Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase. Toxins (Basel). 2020 Feb 18;12(2):127. doi: 10.3390/toxins12020127.
PMID: 32085529
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Stroke
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
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 is available via the Clinical Study Data Request site (click on the link provided below)
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: https://clinicalstudydatarequest.com/Posting.aspx?ID=20343
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