<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/NCT02207244</url>
  </required_header>
  <id_info>
    <org_study_id>CR105048</org_study_id>
    <secondary_id>CNTO1959PSO3002</secondary_id>
    <secondary_id>2014-000720-18</secondary_id>
    <nct_id>NCT02207244</nct_id>
  </id_info>
  <brief_title>A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment</brief_title>
  <acronym>VOYAGE 2</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab&#xD;
      (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis&#xD;
      (scaly skin rash).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (assignment of study drug by chance), double-blind (neither the&#xD;
      participant or study staff will know the identity of study drugs), placebo- (inactive&#xD;
      substance identical in appearance to study drug) and active-comparator-controlled (use of an&#xD;
      approved drug to compare with study drug) study of guselkumab. The active comparator study&#xD;
      drug is adalimumab, an approved drug for the treatment of moderate to severe plaque&#xD;
      psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly&#xD;
      assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg&#xD;
      dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III&#xD;
      (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all&#xD;
      participants will be based on their level of response. All participants will receive&#xD;
      guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at&#xD;
      Week 264 (open label treatment period). The end of the study is defined as the time the last&#xD;
      participant completes the Week 264 visit. The total duration of the study will be&#xD;
      approximately 268 weeks (includes a 4-week screening period). Participants will be monitored&#xD;
      for safety throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2014</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2015</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 Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response</measure>
    <time_frame>Through Week 48</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Week 16</time_frame>
    <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response</measure>
    <time_frame>Through Week 72</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved PASI 90 Response at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved PASI 75 Response at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">992</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab [two 0.8 milliliter (mL) injections] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. Placebo for adalimumab (two 0.8 mL injections) at week 0, followed by one 0.8 mL injection at weeks 1, 3, and 5, and q2w through week 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive adalimumab 80 mg (two 40 mg [0.8 mL] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guselkumab 100 mg</intervention_name>
    <description>100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
    <other_name>CNTO 1959</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for guselkumab</intervention_name>
    <description>Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.</description>
    <arm_group_label>Group III</arm_group_label>
    <other_name>HUMIRA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for adalimumab</intervention_name>
    <description>Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at&#xD;
             least 6 months before the first administration of study agent&#xD;
&#xD;
          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (&gt;=) 12 at&#xD;
             Screening and at Baseline&#xD;
&#xD;
          -  Have an Investigator's Global Assessment (IGA) score &gt;=3 at Screening and at Baseline&#xD;
&#xD;
          -  Have an involved body surface area (BSA) &gt;=10 percent (%) at Screening and at Baseline&#xD;
&#xD;
          -  Must be a candidate for either systemic therapy or phototherapy for psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate,&#xD;
             or pustular) or with current drug-induced psoriasis (for example, a new onset of&#xD;
             psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel&#xD;
             blockers, or lithium)&#xD;
&#xD;
          -  Participants who have ever received guselkumab or adalimumab&#xD;
&#xD;
          -  History or current signs or symptoms of severe, progressive, or uncontrolled renal,&#xD;
             hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,&#xD;
             hematologic, rheumatologic, psychiatric, or metabolic disturbances&#xD;
&#xD;
          -  Has any condition that, in the opinion of the investigator, would make participation&#xD;
             not be in the best interest (for example, compromise the well-being) of the&#xD;
             participant or that could prevent, limit, or confound the protocol-specified&#xD;
             assessments&#xD;
&#xD;
          -  Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months&#xD;
             following the last administration of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rolling Meadows</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Gratiot</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Benowa</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hectorville</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parkville</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmead</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jihlava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nachod</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pardubice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plzen</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 5</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Usti nad Labem</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gera</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lubeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Witten</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chelyabinsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cherepovets</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bilbao Vizcaya</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pontevedra</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>August 4, 2017</results_first_submitted>
  <results_first_submitted_qc>September 28, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</results_first_posted>
  <disposition_first_submitted>July 12, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 12, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 14, 2016</disposition_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Plaque-type psoriasis</keyword>
  <keyword>Guselkumab</keyword>
  <keyword>Adalimumab</keyword>
  <keyword>CNTO 1959</keyword>
  <keyword>Monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo (Week 0 - 16)</title>
          <description>Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).</description>
        </group>
        <group group_id="P2">
          <title>Guselkumab 100 mg (Week 0 - 16)</title>
          <description>Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.</description>
        </group>
        <group group_id="P3">
          <title>Adalimumab (Week 0 - 16)</title>
          <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.</description>
        </group>
        <group group_id="P4">
          <title>Placebo Then Guselkumab 100 mg (Week 16 - 28)</title>
          <description>Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).</description>
        </group>
        <group group_id="P5">
          <title>Guselkumab 100 mg (Week 16 - 28)</title>
          <description>Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.</description>
        </group>
        <group group_id="P6">
          <title>Adalimumab (Week 16 - 28)</title>
          <description>Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.</description>
        </group>
        <group group_id="P7">
          <title>Placebo Then Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (&gt;=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
        </group>
        <group group_id="P8">
          <title>Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
        </group>
        <group group_id="P9">
          <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
        </group>
        <group group_id="P10">
          <title>Adalimumab (After ACP)</title>
          <description>Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of &gt;=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.</description>
        </group>
        <group group_id="P11">
          <title>Guselkumab Combined</title>
          <description>All participants who received guselkumab 100 mg subcutaneously q8w at Week 76 and thereafter through Week 252.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo Controlled Period: Week 0-16</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="248"/>
                <participants group_id="P2" count="496"/>
                <participants group_id="P3" count="248"/>
                <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_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="248"/>
                <participants group_id="P2" count="494"/>
                <participants group_id="P3" count="248"/>
                <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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="478"/>
                <participants group_id="P3" count="237"/>
                <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_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="11"/>
                <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_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
                <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_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_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="3"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>OTHER</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Placebo Crossover and ACP: Week 16-28</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="233"/>
                <participants group_id="P5" count="478"/>
                <participants group_id="P6" count="237"/>
                <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_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="227"/>
                <participants group_id="P5" count="470"/>
                <participants group_id="P6" count="228"/>
                <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_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="6"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="9"/>
                <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_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <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_list>
            </drop_withdraw_reason>
            <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="2"/>
                <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_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="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <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_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="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants 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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Withdrawal and Re-treatment: Week 28-72</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="227"/>
                <participants group_id="P8" count="470"/>
                <participants group_id="P9" count="220"/>
                <participants group_id="P10" count="8"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Nonresponders</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="80"/>
                <participants group_id="P8" count="95"/>
                <participants group_id="P9" count="112"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Responders at Week 28</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="375">Participants randomized to withdrawal=182 and maintenance= 193</participants>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Responders at Week 28 and Withdrawn From Treatment</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="147"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="108"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" 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="213"/>
                <participants group_id="P8" count="443"/>
                <participants group_id="P9" count="211"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" 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="14"/>
                <participants group_id="P8" count="27"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="8"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</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="2"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="1"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" 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="2"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" 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="2"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" 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="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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="2"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants not retreated with guselkumab</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="8"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label Guselkumab: Week 72-264</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="211"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="656"/>
              </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="173"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="554"/>
              </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="38"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="102"/>
              </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="10"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="2"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" 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="5"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="26"/>
              </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="12"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="21"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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="8"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</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="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
        </group>
        <group group_id="B2">
          <title>Guselkumab 100 mg</title>
          <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.</description>
        </group>
        <group group_id="B3">
          <title>Adalimumab</title>
          <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and thereafter through week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="248"/>
            <count group_id="B2" value="496"/>
            <count group_id="B3" value="248"/>
            <count group_id="B4" value="992"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="234"/>
                    <measurement group_id="B2" value="470"/>
                    <measurement group_id="B3" value="237"/>
                    <measurement group_id="B4" value="941"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="43.3" spread="12.38"/>
                    <measurement group_id="B2" value="43.7" spread="12.23"/>
                    <measurement group_id="B3" value="43.2" spread="11.92"/>
                    <measurement group_id="B4" value="43.5" spread="12.18"/>
                  </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="75"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="300"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="170"/>
                    <measurement group_id="B4" value="692"/>
                  </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>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Democratic People'S Republic Of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="248"/>
                <count group_id="O2" value="496"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5"/>
                    <measurement group_id="O2" value="84.1"/>
                  </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 (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="248"/>
                <count group_id="O2" value="496"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 24</time_frame>
        <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8"/>
                    <measurement group_id="O2" value="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 24</time_frame>
        <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5"/>
                    <measurement group_id="O2" value="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 24</time_frame>
        <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12. Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) q2w from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.2"/>
                    <measurement group_id="O2" value="54.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.</description>
        <time_frame>Through Week 48</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.</population>
        <group_list>
          <group group_id="O1">
            <title>Withdrawal Group</title>
            <description>Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 48 until loss of &gt;=50% in the improvement in PASI.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab Maintenance Group</title>
            <description>Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 44 and placebo matched to guselkumab SC injection at Weeks 32, 40 and 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.</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="181"/>
                <count group_id="O2" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the log-rank test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="248"/>
                <count group_id="O2" value="495"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="6.85"/>
                    <measurement group_id="O2" value="-11.23" spread="6.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.1"/>
                    <measurement group_id="O2" value="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= -10.0%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>16.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.0</ci_lower_limit>
            <ci_upper_limit>23.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0"/>
                    <measurement group_id="O2" value="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= -10.0%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>23.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.0</ci_lower_limit>
            <ci_upper_limit>30.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="496"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3"/>
                    <measurement group_id="O2" value="68.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= -10%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in percentage</param_type>
            <param_value>17.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.4</ci_lower_limit>
            <ci_upper_limit>24.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.</description>
        <time_frame>Week 16</time_frame>
        <population>Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (&gt;=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.</description>
          <population>Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (&gt;=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</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="202"/>
                <count group_id="O2" value="408"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                    <measurement group_id="O2" value="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
          <population>PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="23.67"/>
                    <measurement group_id="O2" value="-40.4" spread="26.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on ANOVA model stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
        <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
        <time_frame>Week 24</time_frame>
        <population>PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab 100 mg</title>
            <description>Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and1 2, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and every other Week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
          <description>The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
          <population>PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.</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="410"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1"/>
                    <measurement group_id="O2" value="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.</description>
        <time_frame>Through Week 72</time_frame>
        <population>Population analyzed included PASI 90 responders at Week 28 and who were randomized at Week 28 and treated with guselkumab. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Withdrawal Group</title>
            <description>Participants in withdrawal group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w through Week 15 to maintain the blind during PCP. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants who were PASI 90 responders at Week 28 were randomized to receive placebo matched to guselkumab SC injection at Week 28 and q4w thereafter through Week 72 until loss of &gt;=50% in the improvement in PASI.</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab Maintenance Group</title>
            <description>Participants of maintenance group received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, 7, and q2w through Week 15. Participants received placebo matched to guselkumab SC injection at Week 16 then guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at q2w from Week 17 through Week 23. These participants were PASI 90 responders who were randomized to receive guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32, 40 and thereafter through Week 72.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.</description>
          <population>Population analyzed included PASI 90 responders at Week 28 and who were randomized at Week 28 and treated with guselkumab. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="181"/>
                <count group_id="O2" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved PASI 90 Response at Week 252</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved PASI 90 Response at Week 252</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="560"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0"/>
                    <measurement group_id="O2" value="79.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved PASI 75 Response at Week 252</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved PASI 75 Response at Week 252</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="560"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.4"/>
                    <measurement group_id="O2" value="92.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="559"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0"/>
                    <measurement group_id="O2" value="83.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</title>
        <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score &gt;1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</title>
          <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score &gt;1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="550"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.1"/>
                    <measurement group_id="O2" value="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</title>
        <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</title>
          <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="460"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0"/>
                    <measurement group_id="O2" value="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</title>
        <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
            <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</title>
          <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="461"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline (Week 0) up to Week 264</time_frame>
      <desc>Safety analysis: all participants who were randomized at Week 0, received &gt;=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Week 0 - 16)</title>
          <description>Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).</description>
        </group>
        <group group_id="E2">
          <title>Guselkumab 100 mg (Week 0 - 16)</title>
          <description>Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.</description>
        </group>
        <group group_id="E3">
          <title>Adalimumab (Week 0 - 16)</title>
          <description>Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.</description>
        </group>
        <group group_id="E4">
          <title>Placebo Then Guselkumab 100 mg (Week 16 - 28)</title>
          <description>Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).</description>
        </group>
        <group group_id="E5">
          <title>Guselkumab 100 mg (Week 16 - 28)</title>
          <description>Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.</description>
        </group>
        <group group_id="E6">
          <title>Adalimumab (Week 16 - 28)</title>
          <description>Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.</description>
        </group>
        <group group_id="E7">
          <title>Placebo Then Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (&gt;=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
        </group>
        <group group_id="E8">
          <title>Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of &gt;=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.</description>
        </group>
        <group group_id="E9">
          <title>Adalimumab Then Guselkumab 100 mg (Week 28 - 264)</title>
          <description>Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 36 and q8w through Week 72. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 72 or until loss of &gt;=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252. The presentation of data from the adalimumab group from Week 28 to Week 264 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 264) and adalimumab (After ACP) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).</description>
        </group>
        <group group_id="E10">
          <title>Adalimumab (After ACP)</title>
          <description>Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of &gt;=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23.0</default_vocab>
        <default_assessment>Non-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="3" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="36" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="66" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="36" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal Vein Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal Perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Irritable Bowel Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Submaxillary Gland Enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cholecystitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Appendicitis Perforated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Chronic Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Chronic Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Disseminated Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hiv Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Injection Site Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peritonsillar Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pilonidal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Soft Tissue Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vestibular Neuronitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chest Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Craniocerebral Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eye Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Joint Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lower Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Meniscus Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Multiple Fractures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Multiple Injuries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nerve Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Spinal Cord Injury Cervical</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Subdural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ulnar Nerve Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Psoriatic Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>B-Cell Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Benign Neoplasm of Thyroid Gland</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Bronchial Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Endometrial Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ependymoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of Breast</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Inflammatory Pseudotumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Osteochondroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma Stage Iv</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rectal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinonasal Papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar Stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diabetic Coma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myelitis Transverse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myelopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral Nerve Lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral Nerve Paresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ectopic Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ovarian Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Uterine Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Septum Deviation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pulmonary Fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinus Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sleep Apnoea Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Miscarriage of Partner</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Varicose Vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 23.0</default_vocab>
        <default_assessment>Non-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="60" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="51" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="63" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="45" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="144" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="297" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="159" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="15" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="15" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="21" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="11" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="67" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="142" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="81" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="18" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="32" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="11" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="39" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="111" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="49" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="46" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="22" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="18" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="25" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="16" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="31" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="13" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="248"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="494"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="248"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="481"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="240"/>
                <counts group_id="E7" subjects_affected="27" subjects_at_risk="229"/>
                <counts group_id="E8" subjects_affected="43" subjects_at_risk="473"/>
                <counts group_id="E9" subjects_affected="20" subjects_at_risk="220"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="11"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207244
org study id: CR105048
secondary id: CNTO1959PSO3002
secondary id: 2014-000720-18
nct id: NCT02207244
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis
      (scaly skin rash).
This is a randomized (assignment of study drug by chance), double-blind (neither the
      participant or study staff will know the identity of study drugs), placebo- (inactive
      substance identical in appearance to study drug) and active-comparator-controlled (use of an
      approved drug to compare with study drug) study of guselkumab. The active comparator study
      drug is adalimumab, an approved drug for the treatment of moderate to severe plaque
      psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly
      assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg
      dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III
      (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all
      participants will be based on their level of response. All participants will receive
      guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at
      Week 264 (open label treatment period). The end of the study is defined as the time the last
      participant completes the Week 264 visit. The total duration of the study will be
      approximately 268 weeks (includes a 4-week screening period). Participants will be monitored
      for safety throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
time frame: Week 16
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
time frame: Week 24
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24
time frame: Week 24
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24
time frame: Week 24
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response
time frame: Through Week 48
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Baseline, Week 16
description: The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Week 16
description: The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.
measure: Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Baseline and Week 16
description: The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
measure: Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
time frame: Week 24
description: The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
measure: Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response
time frame: Through Week 72
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.
measure: Percentage of Participants Who Achieved PASI 90 Response at Week 252
time frame: Week 252
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved PASI 75 Response at Week 252
time frame: Week 252
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
time frame: Week 252
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
time frame: Week 252
description: The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
time frame: Week 252
description: The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
time frame: Week 252
description: The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
arm group label: Group I
arm group type: Experimental
description: Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab [two 0.8 milliliter (mL) injections] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.
arm group label: Group II
arm group type: Placebo Comparator
description: Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. Placebo for adalimumab (two 0.8 mL injections) at week 0, followed by one 0.8 mL injection at weeks 1, 3, and 5, and q2w through week 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.
arm group label: Group III
arm group type: Active Comparator
description: Participants will receive adalimumab 80 mg (two 40 mg [0.8 mL] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.
intervention type: Drug
intervention name: Guselkumab 100 mg
description: 100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.
arm group label: Group I
arm group label: Group II
arm group label: Group III
other name: CNTO 1959
intervention type: Drug
intervention name: Placebo for guselkumab
description: Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
arm group label: Group I
arm group label: Group II
arm group label: Group III
intervention type: Drug
intervention name: Adalimumab
description: 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.
arm group label: Group III
other name: HUMIRA®
intervention type: Drug
intervention name: Placebo for adalimumab
description: Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
arm group label: Group I
arm group label: Group II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Canada
country: Czechia
country: Germany
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Adalimumab
mesh term: Antibodies, Monoclonal
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reported events: 
certain agreements: 
limitations and caveats: All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.
point of contact: 