<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/NCT01695239</url>
  </required_header>
  <id_info>
    <org_study_id>13731</org_study_id>
    <secondary_id>I1F-MC-RHAP</secondary_id>
    <nct_id>NCT01695239</nct_id>
  </id_info>
  <brief_title>A Study of Ixekizumab in Participants With Active Psoriatic Arthritis</brief_title>
  <acronym>SPIRIT-P1</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo&#xD;
      in participants with active psoriatic arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR20 Response</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</measure>
    <time_frame>Week 12</time_frame>
    <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Enthesitis Index (LEI)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no fatigue&quot; and 10 representing &quot;as bad as you can imagine.&quot; Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)</measure>
    <time_frame>Week 24</time_frame>
    <description>The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline</measure>
    <time_frame>Week 24</time_frame>
    <description>The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Body Surface Area (BSA)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in American College of Rheumatology-N (ACR-N) Score</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender Joint Counts (TJC)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Counts (SJC)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Assessment of Pain VAS</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician's Global Assessment of Disease Activity VAS</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
    <description>The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-Reactive Protein (CRP)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Enthesitis Index (LEI)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</measure>
    <time_frame>Week 24</time_frame>
    <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Itching Severity Using the Itch NRS</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">417</enrollment>
  <condition>Psoriasis, Arthritic</condition>
  <arm_group>
    <arm_group_label>Ixekizumab Q2W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ixekizumab Q4W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by 80 mg SC injection every 4 weeks (Q4W).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for ixekizumab and placebo for adalimumab administered by SC injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab Q2W</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered by 40 mg SC injection Q2W.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ixekizumab</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Ixekizumab Q2W</arm_group_label>
    <arm_group_label>Ixekizumab Q4W</arm_group_label>
    <other_name>LY2439821</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Adalimumab Q2W</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presents with established diagnosis of active psoriatic arthritis for at least 6&#xD;
             months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria&#xD;
&#xD;
          -  Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at&#xD;
             least 3 swollen joints&#xD;
&#xD;
          -  Presence of active psoriatic skin lesion or a personal history of plaque psoriasis&#xD;
             (Ps)&#xD;
&#xD;
          -  Men must agree to use a reliable method of birth control or remain abstinent during&#xD;
             the study&#xD;
&#xD;
          -  Women must agree to use reliable birth control or remain abstinent during the study&#xD;
             and for at least 12 weeks after stopping treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior use of biologic agents for treatment of Ps or PsA&#xD;
&#xD;
          -  Inadequate response to greater than or equal to 4 conventional disease-modifying&#xD;
             antirheumatic drugs (DMARDs)&#xD;
&#xD;
          -  Current use of more than one conventional DMARD&#xD;
&#xD;
          -  Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other&#xD;
             than PsA&#xD;
&#xD;
          -  Have participated in any study with interleukin 17 (IL-17) antagonists, including&#xD;
             ixekizumab&#xD;
&#xD;
          -  Serious disorder or illness other than psoriatic arthritis&#xD;
&#xD;
          -  Serious infection within the last 3 months&#xD;
&#xD;
          -  Breastfeeding or nursing (lactating) women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tuscaloosa</city>
        <state>Alabama</state>
        <zip>35406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <zip>32073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <zip>33542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Cumberland</city>
        <state>Maryland</state>
        <zip>21502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Clarksburg</city>
        <state>West Virginia</state>
        <zip>26301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sliven</city>
        <zip>8800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 1A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Quebec</city>
        <zip>G1V3M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brno</city>
        <zip>638 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bruntal</city>
        <zip>79201</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <country>Czechia</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>722 00</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>15800</zip>
        <country>Czechia</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>33076</zip>
        <country>France</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>44093</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>45032</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>7600SZ</zip>
        <country>Netherlands</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>6229 HX</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>3079 DZ</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>158-79</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>40-635</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>31-501</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>20-582</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>60-539</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>63-000</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>02-118</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>51-124</zip>
        <country>Poland</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>656024</zip>
        <country>Russian Federation</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>620102</zip>
        <country>Russian Federation</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>420097</zip>
        <country>Russian Federation</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>115522</zip>
        <country>Russian Federation</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>185019</zip>
        <country>Russian Federation</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>193257</zip>
        <country>Russian Federation</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>08034</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>48013</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>14004</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>28222</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>29009</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>08208</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>39008</zip>
        <country>Spain</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>49044</zip>
        <country>Ukraine</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>83045</zip>
        <country>Ukraine</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>76008</zip>
        <country>Ukraine</country>
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    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>61176</zip>
        <country>Ukraine</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>03680</zip>
        <country>Ukraine</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>43024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>79011</zip>
        <country>Ukraine</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>65026</zip>
        <country>Ukraine</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Goodmayes</city>
        <state>Essex</state>
        <zip>IG7 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wolverhampton</city>
        <state>West Midlands</state>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD5 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>South Africa</country>
  </removed_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>April 20, 2016</results_first_submitted>
  <results_first_submitted_qc>September 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 27, 2016</results_first_posted>
  <disposition_first_submitted>September 3, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 3, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 18, 2015</disposition_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Ixekizumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by the combined extension period and long-term extension period from Week 24 to Week 156.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo (PBO)</title>
          <description>Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.</description>
        </group>
        <group group_id="P2">
          <title>Adalimumab (ADA) Q2W</title>
          <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="P3">
          <title>Ixe Q4W</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="P4">
          <title>Ixe Q2W</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="P5">
          <title>Inadequate Responders (IR)/Ixe Q4W</title>
          <description>Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.</description>
        </group>
        <group group_id="P6">
          <title>IR/Ixe Q2W</title>
          <description>Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.</description>
        </group>
        <group group_id="P7">
          <title>IR PBO Washout</title>
          <description>Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24.</description>
        </group>
        <group group_id="P8">
          <title>PBO Washout</title>
          <description>Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.</description>
        </group>
        <group group_id="P9">
          <title>Ixe Q4W/Ixe Q4W</title>
          <description>Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.</description>
        </group>
        <group group_id="P10">
          <title>Ixe Q2W/Ixe Q2W</title>
          <description>Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.</description>
        </group>
        <group group_id="P11">
          <title>Placebo Post-Treatment Follow-up Period</title>
          <description>Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="P12">
          <title>Adalimumab Post-Treatment Follow-up Period</title>
          <description>Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="P13">
          <title>Ixekizumab 80mg Q4W Post-Treatment Follow-up Period</title>
          <description>Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="P14">
          <title>Ixekizumab 80mg Q2W Post-Treatment Follow-up Period</title>
          <description>Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind (DB) Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="103"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="102"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Classified as Inadequate Responder (IR)</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="97"/>
                <participants group_id="P4" count="96"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Entry Criteria Not Met</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </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 group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>IR Participants (Week 16 Up To Week 24)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Only inadequate responders were included.</participants>
                <participants group_id="P2" count="0">Only inadequate responders were included.</participants>
                <participants group_id="P3" count="0">Only inadequate responders were included.</participants>
                <participants group_id="P4" count="0">Only inadequate responders were included.</participants>
                <participants group_id="P5" count="24">IR from placebo who re-randomized to ixeQ4W and IR from ixeQ4W.</participants>
                <participants group_id="P6" count="24">IR from placebo who re-randomized to ixeQ2W and IR from ixeQ2W.</participants>
                <participants group_id="P7" count="9">Adalimumab Q2W (IR) who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.</participants>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="24"/>
                <participants group_id="P6" count="24"/>
                <participants group_id="P7" count="9"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Placebo Washout (Week 24 Up To Week 32)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0">Only included PBO washout participants.</participants>
                <participants group_id="P6" count="0">Only included PBO washout participants.</participants>
                <participants group_id="P7" count="0">Only included PBO washout participants.</participants>
                <participants group_id="P8" count="88">Adalimumab Q2W responders who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.</participants>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="77"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="11"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Entry Criteria Not Met</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extension Long-Term Extension Periods</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0">Only included combined extension participants.</participants>
                <participants group_id="P9" count="187">IxeQ4W who re-randomized to ixeQ4W.</participants>
                <participants group_id="P10" count="183">IxeQ2W who re-randomized to ixeQ2W.</participants>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="121"/>
                <participants group_id="P10" count="122"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="66"/>
                <participants group_id="P10" count="61"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="37"/>
                <participants group_id="P10" count="31"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="15"/>
                <participants group_id="P10" count="21"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="7"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Post-Treatment Follow-Up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0">Only included post-treatment follow-up participants.</participants>
                <participants group_id="P10" count="0">Only included post-treatment follow-up participants.</participants>
                <participants group_id="P11" count="20">Participants who discontinued early and received PBO.</participants>
                <participants group_id="P12" count="1">Participants who discontinued early and received adalimumab.</participants>
                <participants group_id="P13" count="165">IxeQ4W participants who entered post-treatment follow-up.</participants>
                <participants group_id="P14" count="171">IxeQ2W participants who entered post-treatment follow-up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="20"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="156"/>
                <participants group_id="P14" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="9"/>
                <participants group_id="P14" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="B2">
          <title>ADA Q2W</title>
          <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="B3">
          <title>Ixe Q4W</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="B4">
          <title>Ixe Q2W</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="106"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="107"/>
            <count group_id="B4" value="103"/>
            <count group_id="B5" value="417"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.60" spread="12.32"/>
                    <measurement group_id="B2" value="48.58" spread="12.43"/>
                    <measurement group_id="B3" value="49.07" spread="10.07"/>
                    <measurement group_id="B4" value="49.79" spread="12.62"/>
                    <measurement group_id="B5" value="49.52" spread="11.87"/>
                  </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="58"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="55"/>
                    <measurement group_id="B5" value="225"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="96"/>
                    <measurement group_id="B5" value="392"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="94"/>
                    <measurement group_id="B4" value="87"/>
                    <measurement group_id="B5" value="356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])</title>
        <description>ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])</title>
          <description>ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).</description>
          <population>All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2"/>
                    <measurement group_id="O2" value="57.4"/>
                    <measurement group_id="O3" value="57.9"/>
                    <measurement group_id="O4" value="62.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR20 Response</title>
        <description>ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
        <time_frame>Week 12</time_frame>
        <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR20 Response</title>
          <description>ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
          <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1"/>
                    <measurement group_id="O2" value="51.5"/>
                    <measurement group_id="O3" value="57.0"/>
                    <measurement group_id="O4" value="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response</title>
        <description>ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response</title>
          <description>ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
          <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                    <measurement group_id="O2" value="38.6"/>
                    <measurement group_id="O3" value="40.2"/>
                    <measurement group_id="O4" value="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score</title>
        <description>ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score</title>
          <description>ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.</description>
          <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="25.7"/>
                    <measurement group_id="O3" value="23.4"/>
                    <measurement group_id="O4" value="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
        <description>HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post baseline HAQ-DI data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
          <description>HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post baseline HAQ-DI data.</population>
          <units>units 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="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1797" spread="0.0524"/>
                    <measurement group_id="O2" value="-0.3712" spread="0.0510"/>
                    <measurement group_id="O3" value="-0.4431" spread="0.0503"/>
                    <measurement group_id="O4" value="-0.4963" spread="0.0507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])</title>
        <description>The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post baseline mTSS data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])</title>
          <description>The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.</description>
          <population>All randomized participants with baseline and post baseline mTSS data.</population>
          <units>units 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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="0.086"/>
                    <measurement group_id="O2" value="0.10" spread="0.085"/>
                    <measurement group_id="O3" value="0.17" spread="0.082"/>
                    <measurement group_id="O4" value="0.08" spread="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</title>
        <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
        <time_frame>Week 12</time_frame>
        <population>All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</title>
          <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
          <population>All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PASI 75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="33.8"/>
                    <measurement group_id="O3" value="75.3"/>
                    <measurement group_id="O4" value="69.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="22.1"/>
                    <measurement group_id="O3" value="52.1"/>
                    <measurement group_id="O4" value="57.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="14.7"/>
                    <measurement group_id="O3" value="31.5"/>
                    <measurement group_id="O4" value="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
        <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
          <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
          <population>All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.</population>
          <units>units 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="57"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.24"/>
                    <measurement group_id="O2" value="-0.8" spread="0.24"/>
                    <measurement group_id="O3" value="-0.9" spread="0.21"/>
                    <measurement group_id="O4" value="-1.5" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
        <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants who had baseline psoriatic lesion(s) involving &gt;=3% BSA, baseline itch NRS score and post baseline itch NRS score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
          <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline psoriatic lesion(s) involving &gt;=3% BSA, baseline itch NRS score and post baseline itch NRS score.</population>
          <units>units 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="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.27"/>
                    <measurement group_id="O2" value="-1.4" spread="0.28"/>
                    <measurement group_id="O3" value="-2.6" spread="0.27"/>
                    <measurement group_id="O4" value="-2.8" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
        <description>The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no fatigue&quot; and 10 representing &quot;as bad as you can imagine.&quot; Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline and post baseline fatigue NRS data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
          <description>The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no fatigue&quot; and 10 representing &quot;as bad as you can imagine.&quot; Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline and post baseline fatigue NRS data.</population>
          <units>units 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="103"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.25"/>
                    <measurement group_id="O2" value="-1.5" spread="0.24"/>
                    <measurement group_id="O3" value="-1.6" spread="0.24"/>
                    <measurement group_id="O4" value="-1.9" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)</title>
        <description>JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)</title>
          <description>JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.</description>
          <population>All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.</population>
          <units>units 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="91"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Joint Space Narrowing Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.031"/>
                    <measurement group_id="O2" value="0.01" spread="0.031"/>
                    <measurement group_id="O3" value="0.04" spread="0.030"/>
                    <measurement group_id="O4" value="0.01" spread="0.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Erosion Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="0.077"/>
                    <measurement group_id="O2" value="0.12" spread="0.077"/>
                    <measurement group_id="O3" value="0.15" spread="0.075"/>
                    <measurement group_id="O4" value="0.08" spread="0.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
        <description>SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])</title>
          <description>SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.</population>
          <units>units 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="99"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="98"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="0.958"/>
                    <measurement group_id="O2" value="6.78" spread="0.904"/>
                    <measurement group_id="O3" value="7.45" spread="0.894"/>
                    <measurement group_id="O4" value="8.24" spread="0.898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="1.013"/>
                    <measurement group_id="O2" value="4.22" spread="0.943"/>
                    <measurement group_id="O3" value="4.86" spread="0.933"/>
                    <measurement group_id="O4" value="3.39" spread="0.936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])</title>
        <description>The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline and post baseline QIDS-SR16 data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])</title>
          <description>The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline and post baseline QIDS-SR16 data.</population>
          <units>units 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="101"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.36"/>
                    <measurement group_id="O2" value="-1.6" spread="0.33"/>
                    <measurement group_id="O3" value="-0.8" spread="0.32"/>
                    <measurement group_id="O4" value="-0.7" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease</title>
        <description>The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline and post baseline DAS28-CRP data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease</title>
          <description>The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.</description>
          <population>All randomized participants who had baseline and post baseline DAS28-CRP data.</population>
          <units>units 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="104"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="106"/>
                <count group_id="O4" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.835" spread="0.1307"/>
                    <measurement group_id="O2" value="-1.743" spread="0.1215"/>
                    <measurement group_id="O3" value="-1.955" spread="0.1206"/>
                    <measurement group_id="O4" value="-2.036" spread="0.1225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)</title>
        <description>The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)</title>
          <description>The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.</description>
          <population>All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.1"/>
                    <measurement group_id="O2" value="58.4"/>
                    <measurement group_id="O3" value="57.9"/>
                    <measurement group_id="O4" value="66.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline</title>
        <description>The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline</title>
          <description>The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.</description>
          <population>All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="41"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1"/>
                    <measurement group_id="O2" value="62.2"/>
                    <measurement group_id="O3" value="65.4"/>
                    <measurement group_id="O4" value="73.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Body Surface Area (BSA)</title>
        <description>The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Surface Area (BSA)</title>
          <description>The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.</population>
          <units>percent change in BSA</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="99"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="1.36"/>
                    <measurement group_id="O2" value="-9.5" spread="1.35"/>
                    <measurement group_id="O3" value="-12.0" spread="1.32"/>
                    <measurement group_id="O4" value="-10.6" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline</title>
        <description>The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline</title>
          <description>The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.</population>
          <units>units 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="69"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="1.66"/>
                    <measurement group_id="O2" value="-10.7" spread="1.49"/>
                    <measurement group_id="O3" value="-14.0" spread="1.54"/>
                    <measurement group_id="O4" value="-15.5" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)</title>
        <description>The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)</title>
          <description>The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.</population>
          <units>units 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="39"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.4" spread="6.53"/>
                    <measurement group_id="O2" value="-57.1" spread="7.84"/>
                    <measurement group_id="O3" value="-57.1" spread="5.67"/>
                    <measurement group_id="O4" value="-48.3" spread="6.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</title>
        <description>The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline axial involvement defined as baseline BASDAI score &gt;4, baseline BASDAI score and post baseline BASDAI score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</title>
          <description>The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline axial involvement defined as baseline BASDAI score &gt;4, baseline BASDAI score and post baseline BASDAI score.</population>
          <units>units 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="75"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.25" spread="0.268"/>
                    <measurement group_id="O2" value="-2.42" spread="0.249"/>
                    <measurement group_id="O3" value="-2.74" spread="0.234"/>
                    <measurement group_id="O4" value="-2.91" spread="0.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)</title>
        <description>Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)</title>
          <description>Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.</description>
          <population>All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Emergent (TE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NAb</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in American College of Rheumatology-N (ACR-N) Score</title>
        <description>The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants with post-baseline ACR data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in American College of Rheumatology-N (ACR-N) Score</title>
          <description>The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.</description>
          <population>All randomized participants with post-baseline ACR data.</population>
          <units>percent change</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.182" spread="6.1417"/>
                    <measurement group_id="O2" value="28.517" spread="5.9189"/>
                    <measurement group_id="O3" value="33.509" spread="5.8905"/>
                    <measurement group_id="O4" value="30.391" spread="5.9736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender Joint Counts (TJC)</title>
        <description>TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post-baseline TJC data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender Joint Counts (TJC)</title>
          <description>TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline TJC data.</population>
          <units>joint counts</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="106"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="1.14"/>
                    <measurement group_id="O2" value="-10.1" spread="1.10"/>
                    <measurement group_id="O3" value="-11.9" spread="1.08"/>
                    <measurement group_id="O4" value="-13.6" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Counts (SJC)</title>
        <description>SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post-baseline SJC data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Counts (SJC)</title>
          <description>SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline SJC data.</population>
          <units>joint counts</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="106"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="0.62"/>
                    <measurement group_id="O2" value="-6.1" spread="0.59"/>
                    <measurement group_id="O3" value="-7.0" spread="0.59"/>
                    <measurement group_id="O4" value="-8.3" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Assessment of Pain VAS</title>
        <description>The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post-baseline patient's assessment of pain data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Assessment of Pain VAS</title>
          <description>The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline patient's assessment of pain data.</population>
          <units>units 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="105"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="104"/>
                <count group_id="O4" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.0" spread="2.68"/>
                    <measurement group_id="O2" value="-30.0" spread="2.52"/>
                    <measurement group_id="O3" value="-29.6" spread="2.51"/>
                    <measurement group_id="O4" value="-31.6" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS</title>
        <description>Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS</title>
          <description>Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.</population>
          <units>units 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="105"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="104"/>
                <count group_id="O4" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.8" spread="2.65"/>
                    <measurement group_id="O2" value="-31.6" spread="2.49"/>
                    <measurement group_id="O3" value="-33.8" spread="2.48"/>
                    <measurement group_id="O4" value="-35.6" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician's Global Assessment of Disease Activity VAS</title>
        <description>The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, 24 Weeks</time_frame>
        <population>All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician's Global Assessment of Disease Activity VAS</title>
          <description>The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.</population>
          <units>units 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="100"/>
                <count group_id="O2" value="88"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.2" spread="2.14"/>
                    <measurement group_id="O2" value="-34.7" spread="2.10"/>
                    <measurement group_id="O3" value="-38.5" spread="2.06"/>
                    <measurement group_id="O4" value="-42.0" spread="1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-Reactive Protein (CRP)</title>
        <description>CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants with baseline and post-baseline CRP data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-Reactive Protein (CRP)</title>
          <description>CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants with baseline and post-baseline CRP data.</population>
          <units>milligram/liter (mg/L)</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="106"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.873" spread="1.4292"/>
                    <measurement group_id="O2" value="-7.512" spread="1.2674"/>
                    <measurement group_id="O3" value="-8.804" spread="1.2602"/>
                    <measurement group_id="O4" value="-8.942" spread="1.2552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
        <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
          <description>The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.</description>
          <population>All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.</population>
          <units>units 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="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.26"/>
                    <measurement group_id="O2" value="-0.9" spread="0.23"/>
                    <measurement group_id="O3" value="-1.3" spread="0.21"/>
                    <measurement group_id="O4" value="-1.4" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</title>
        <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)</title>
          <description>The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.</description>
          <population>All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.</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="38"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PASI 75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                    <measurement group_id="O2" value="55.2"/>
                    <measurement group_id="O3" value="71.2"/>
                    <measurement group_id="O4" value="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="41"/>
                    <count group_id="O4" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                    <measurement group_id="O2" value="37.3"/>
                    <measurement group_id="O3" value="56.2"/>
                    <measurement group_id="O4" value="67.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="23.9"/>
                    <measurement group_id="O3" value="42.5"/>
                    <measurement group_id="O4" value="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Itching Severity Using the Itch NRS</title>
        <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who had baseline psoriatic lesion(s) involving &gt;=3% BSA, baseline itch NRS score and post baseline itch NRS score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Q2W</title>
            <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O3">
            <title>Ixekizumab Q4W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
          <group group_id="O4">
            <title>Ixekizumab Q2W</title>
            <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itching Severity Using the Itch NRS</title>
          <description>The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing &quot;no itch&quot; and 10 representing &quot;worst itch imaginable.&quot; Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.</description>
          <population>All randomized participants who had baseline psoriatic lesion(s) involving &gt;=3% BSA, baseline itch NRS score and post baseline itch NRS score.</population>
          <units>units 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="67"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.32"/>
                    <measurement group_id="O2" value="-1.7" spread="0.29"/>
                    <measurement group_id="O3" value="-2.9" spread="0.29"/>
                    <measurement group_id="O4" value="-2.8" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were summarized based on all randomized participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (PBO) Double-Blind Period</title>
          <description>Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.</description>
        </group>
        <group group_id="E2">
          <title>Adalimumab (ADA) Double-Blind Period</title>
          <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24</description>
        </group>
        <group group_id="E3">
          <title>Ixe Q2W Double-Blind Period</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E4">
          <title>Ixe Q4W Double-Blind Period</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E5">
          <title>IR IXE Q4W</title>
          <description>Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E6">
          <title>IR IXE Q2W</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E7">
          <title>IR PBO Washout</title>
          <description>Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E8">
          <title>PBO Washout</title>
          <description>Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.</description>
        </group>
        <group group_id="E9">
          <title>IXE Q4W</title>
          <description>Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156.&#xD;
Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156.&#xD;
PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.</description>
        </group>
        <group group_id="E10">
          <title>IXE Q2W</title>
          <description>Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156.&#xD;
Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156.&#xD;
PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.</description>
        </group>
        <group group_id="E11">
          <title>PBO Post-Treatment Follow-Up Period</title>
          <description>Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="E12">
          <title>Adalimumab Post-Treatment Follow-up Period</title>
          <description>Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="E13">
          <title>IXE Q4W Post-Treatment Follow-up Period</title>
          <description>Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
        <group group_id="E14">
          <title>IXE Q2W Post-Treatment Follow-up Period</title>
          <description>Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="107"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E9" subjects_affected="28" subjects_at_risk="187"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="183"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="165"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="5" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Gastroenteritis clostridial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Latent tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Perirenal haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Psoriatic arthropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acoustic neuroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Large intestine benign neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Cervical myelopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Guillain-barre syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Post-traumatic headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired phimosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Bartholin's cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Vulval disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E10" events="4" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="107"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="102"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="88"/>
                <counts group_id="E9" subjects_affected="62" subjects_at_risk="187"/>
                <counts group_id="E10" subjects_affected="66" subjects_at_risk="183"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="11" subjects_affected="7" subjects_at_risk="107"/>
                <counts group_id="E4" events="42" subjects_affected="13" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="6" subjects_affected="3" subjects_at_risk="187"/>
                <counts group_id="E10" events="51" subjects_affected="5" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="31" subjects_affected="13" subjects_at_risk="107"/>
                <counts group_id="E4" events="63" subjects_affected="16" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="63" subjects_affected="12" subjects_at_risk="187"/>
                <counts group_id="E10" events="180" subjects_affected="13" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="107"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="13" subjects_affected="10" subjects_at_risk="187"/>
                <counts group_id="E10" events="11" subjects_affected="10" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E9" events="7" subjects_affected="5" subjects_at_risk="187"/>
                <counts group_id="E10" events="14" subjects_affected="12" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="107"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E9" events="27" subjects_affected="21" subjects_at_risk="187"/>
                <counts group_id="E10" events="23" subjects_affected="18" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E9" events="32" subjects_affected="21" subjects_at_risk="187"/>
                <counts group_id="E10" events="23" subjects_affected="21" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E9" events="11" subjects_affected="11" subjects_at_risk="187"/>
                <counts group_id="E10" events="6" subjects_affected="6" subjects_at_risk="183"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01695239
org study id: 13731
secondary id: I1F-MC-RHAP
nct id: NCT01695239
lead sponsor: 
has dmc: Yes
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo
      in participants with active psoriatic arthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])
time frame: Week 24
description: ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
measure: Percentage of Participants Achieving ACR20 Response
time frame: Week 12
description: ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
measure: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
time frame: Week 24
description: ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
measure: Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score
time frame: Week 24
description: ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
time frame: Baseline, Week 24
description: HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])
time frame: Baseline, Week 24
description: The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
time frame: Week 12
description: The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
time frame: Baseline, Week 12
description: The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
measure: Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
time frame: Baseline, Week 12
description: The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
time frame: Baseline, Week 24
description: The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)
time frame: Baseline, Week 24
description: JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.
measure: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
time frame: Baseline, Week 24
description: SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])
time frame: Baseline, Week 24
description: The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease
time frame: Baseline, Week 24
description: The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.
measure: Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)
time frame: Week 24
description: The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline
time frame: Week 24
description: The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
measure: Percent Change From Baseline in Body Surface Area (BSA)
time frame: Baseline, Week 24
description: The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline
time frame: Baseline, Week 24
description: The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)
time frame: Baseline, Week 24
description: The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: Baseline, Week 24
description: The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
measure: Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)
time frame: Baseline to Week 24
description: Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.
measure: Percent Change in American College of Rheumatology-N (ACR-N) Score
time frame: Baseline, 24 Weeks
description: The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.
measure: Change From Baseline in Tender Joint Counts (TJC)
time frame: Baseline, Week 24
description: TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Swollen Joint Counts (SJC)
time frame: Baseline, Week 24
description: SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Patient's Assessment of Pain VAS
time frame: Baseline, Week 24
description: The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS
time frame: Baseline, Week 24
description: Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Physician's Global Assessment of Disease Activity VAS
time frame: Baseline, 24 Weeks
description: The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in C-Reactive Protein (CRP)
time frame: Baseline, Week 24
description: CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
time frame: Baseline, Week 24
description: The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
time frame: Week 24
description: The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
measure: Change From Baseline in Itching Severity Using the Itch NRS
time frame: Baseline, Week 24
description: The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
arm group label: Ixekizumab Q2W
arm group type: Experimental
description: Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).
arm group label: Ixekizumab Q4W
arm group type: Experimental
description: Administered by 80 mg SC injection every 4 weeks (Q4W).
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for ixekizumab and placebo for adalimumab administered by SC injection.
arm group label: Adalimumab Q2W
arm group type: Active Comparator
description: Administered by 40 mg SC injection Q2W.
intervention type: Drug
intervention name: Ixekizumab
description: Administered SC
arm group label: Ixekizumab Q2W
arm group label: Ixekizumab Q4W
other name: LY2439821
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo
intervention type: Drug
intervention name: Adalimumab
description: Administered SC
arm group label: Adalimumab Q2W
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Belgium
country: Bulgaria
country: Canada
country: Czechia
country: Estonia
country: France
country: Japan
country: Mexico
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
country: Hungary
country: Ireland
country: South Africa
responsible party type: Sponsor
mesh term: Arthritis, Psoriatic
mesh term: Psoriasis
mesh term: Adalimumab
mesh term: Ixekizumab
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certain agreements: 
point of contact: 