<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/NCT03818035</url>
  </required_header>
  <id_info>
    <org_study_id>CR108514</org_study_id>
    <secondary_id>2018-001238-16</secondary_id>
    <secondary_id>CNTO1959PSO3012</secondary_id>
    <nct_id>NCT03818035</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis</brief_title>
  <acronym>GUIDE</acronym>
  <official_title>A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis&#xD;
      participants who receive on-label guselkumab treatment until week 20 and respond with a&#xD;
      Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of&#xD;
      disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every&#xD;
      16 weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2025</completion_date>
  <primary_completion_date type="Actual">March 7, 2022</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (&lt;) 3 at Week 68</measure>
    <time_frame>Week 68</time_frame>
    <description>Percentage of participants who achieved an absolute PASI &lt;3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percentage [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Improvement From Baseline (Week 0) in PASI Score</measure>
    <time_frame>Group 1: Week 0 up to Week 28; Group 2a, 2b, 2c: Week 28 up to Week 68</time_frame>
    <description>Time to improvement from baseline in PASI (PASI 75/90/100 response and absolute PASI score =0) for participants with short disease duration (SDD) (less than or equal to [&lt;=] 2 years) and longer disease duration (LDD) (greater than [&gt;] 2 years) was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75/90/100 responders were defined as participants with &gt;= 75%, &gt;= 90%, 100% improvement in PASI respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, &lt;=1 and &lt;3 at Weeks 20, 28, 68, 116, 164 and 120</measure>
    <time_frame>Weeks 20, 28, 68, 116, 164 and 120</time_frame>
    <description>Percentage of participants with short (&lt;=2 years) and longer (&gt;2 years) disease duration who achieved an absolute PASI Score of 0, &lt;=1 and less than (&lt;) 3 will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score &lt; 3)</measure>
    <time_frame>Week 68 up to Week 116</time_frame>
    <description>Percentage of participants who retain disease control (that is, absolute PASI score &lt;3 from week 68 through week 116 for participants with short (&lt;= 2 years) and longer (&gt;2 years) disease duration will be reported. Control of disease was defined as participants with a PASI score &lt;3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220</measure>
    <time_frame>Weeks 20, 28, 68, 116, 164, and 220</time_frame>
    <description>Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with &gt;= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with &gt;= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score &gt;5) After Treatment Withdrawal</measure>
    <time_frame>Week 68 up to Week 220</time_frame>
    <description>Time to loss of disease control (absolute PASI score &gt;5) after treatment withdrawal beyond Week 68 up to Week 116 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28</measure>
    <time_frame>Weeks 12, 16, 20 and 28</time_frame>
    <description>Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220</measure>
    <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
    <description>Change from baseline (Week 0) in DLQI score at Weeks 28, 68, 116, 164 and 220 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and &lt;5</measure>
    <time_frame>Weeks 28, 68, 116, 164 and 220</time_frame>
    <description>Percentage of participants who achieved a DLQI score 0/1 and &lt;5 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220</measure>
    <time_frame>Baseline (Week 0), Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220</time_frame>
    <description>Change from baseline in the psoriasis affected BSA (%) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220 will be reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220</measure>
    <time_frame>Baseline (Week 0), 28, 68, 116, 164 and 220</time_frame>
    <description>Change from baseline in NAPPA-QOL at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-QOL was a 20-item nail-specific QoL questionnaire covering past week. Signs, stigma and everyday life were rated on a 5-point scale, ranged from 0 (no suffering) to 4 (high suffering). A global score was computed by averaging all items which ranged from 0 (no suffering) to 4 (high suffering). A decrease in NAPPA QoL score indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220</measure>
    <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
    <description>Change from baseline in NAPPA-PBI at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-PBI was a 24-item questionnaire to assess participant-defined needs before and participant-rated benefits after treatment. The answers were given on a scale from 0 to 4, and a global score was calculated as follows: Each benefit item was multiplied with the respective importance item, and the product is divided by the sum of all importance items. The results were summed up over all items. The resulting global score ranged from 0 (no benefit) to 4 (highest possible benefit). Higher score indicated more benefit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220</measure>
    <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
    <description>Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220</measure>
    <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
    <description>Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of &gt;= 40 points in PSSD symptom score or sign score, and a &gt;= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score &gt;= 1 at Week 28</measure>
    <time_frame>Week 68</time_frame>
    <description>Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score &gt;= 1 at Week 28 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of &gt;= 40 points in PSSD symptom score or sign score, and a &gt;= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level</measure>
    <time_frame>Up to Week 80</time_frame>
    <description>The potential association between trough serum guselkumab concentration and efficacy or serum biomarker level will be analyzed by immunoassays. For the analyses the trough serum guselkumab concentration will be set into relation with the efficacy (e.g. PASI response) or with serum biomarker (e.g. serum IL-17A, IL-17F, IL-22) concentration. Guselkumab and all biomarker concentrations will be measured in the unit of picogram/milliliter (pg/mL). In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score &lt;3 at Week 68</measure>
    <time_frame>Weeks 20, 28, 36, 68</time_frame>
    <description>The potential association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score &lt;3 at Week 68 will be analyzed. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI &gt;5) and Regain Control of Disease (PASI &lt;3) 24 Weeks After Start of Re-Treatment</measure>
    <time_frame>Start of re-treatment up to 24 weeks</time_frame>
    <description>Percentage of participants who were re-treated due to loss of disease control (PASI &gt;5) and regain control of disease (PASI &lt;3) 24 Weeks after start of re-treatment will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to Week 220</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>Week 220</time_frame>
    <description>Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) were reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">880</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Part 1: Guselkumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Guselkumab q8w and Guselkumab q16w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder [SRe]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score &gt;5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Guselkumab q8w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (Non SRe) in group 2c with a PASI score greater than (&gt;) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: Guselkumab Withdrawal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants from groups 2a and 2b with a PASI score &lt;3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to [&gt;=] 3) at week 68 or PASI &gt;5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guselkumab</intervention_name>
    <description>Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.</description>
    <arm_group_label>Part 1: Guselkumab</arm_group_label>
    <arm_group_label>Part 2: Guselkumab q8w</arm_group_label>
    <arm_group_label>Part 2: Guselkumab q8w and Guselkumab q16w</arm_group_label>
    <arm_group_label>Part 3: Guselkumab Withdrawal</arm_group_label>
    <other_name>TREMFYA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Injection</intervention_name>
    <description>Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.</description>
    <arm_group_label>Part 2: Guselkumab q8w</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a disease duration of plaque psoriasis of either less than or equal to (&lt;=2) years&#xD;
             or (greater than (&gt;2) years calculated from date at which first symptoms [plaque] were&#xD;
             reported by subject to date of screening visit at screening; approximately 40&#xD;
             percentage (%) of participants must have a disease duration &lt;=2 years&#xD;
&#xD;
          -  Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index&#xD;
             (PASI) score &gt;10 or affected body surface area (BSA) &gt;10%) and additionally a&#xD;
             Dermatology Life Quality Index (DLQI) score &gt;10 at baseline (week 0)&#xD;
&#xD;
          -  Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history&#xD;
             and/or physical examination&#xD;
&#xD;
          -  Agrees not to receive a live virus or live bacterial vaccination during the study, or&#xD;
             within 3 months after the last administration of study drug&#xD;
&#xD;
          -  Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or&#xD;
             within 12 months after the last administration of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has previously received any therapeutic agent directly targeted to interleukin (IL)&#xD;
             -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab&#xD;
             [BI-655066])&#xD;
&#xD;
          -  Has received any systemic immunosuppressant (for example, methotrexate, azathioprine,&#xD;
             cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus,&#xD;
             fumaric acid esters), or anakinra within 4 weeks of the first administration of study&#xD;
             drug.&#xD;
&#xD;
          -  Tests positive for hepatitis B virus (HBV) infection or who are seropositive for&#xD;
             antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test&#xD;
             results 6 months apart after completing antiviral treatment and prior to baseline and&#xD;
             have a third negative HCV RNA test result at baseline&#xD;
&#xD;
          -  Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g.,&#xD;
             rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first&#xD;
             administration of study drug&#xD;
&#xD;
          -  Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months&#xD;
             before the first administration of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Prive d'Antony</name>
      <address>
        <city>Antony</city>
        <zip>92160</zip>
        <country>France</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Auxerre</name>
      <address>
        <city>Auxerre</city>
        <zip>89011</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Reims Bezanne - De Courlancy</name>
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        <city>Bezanne</city>
        <zip>51430</zip>
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  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
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        <city>Lyon Cedex 03</city>
        <zip>69437</zip>
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  <location>
    <facility>
      <name>Le Bateau Blanc</name>
      <address>
        <city>Martigues</city>
        <zip>13500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice Hopital de l Archet</name>
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        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
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  <location>
    <facility>
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        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
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  <location>
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        <city>Toulon</city>
        <zip>83041</zip>
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  <location>
    <facility>
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        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Universitätsklinikum Aachen</name>
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        <city>Aachen</city>
        <zip>52074</zip>
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    </facility>
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  <location>
    <facility>
      <name>DermaManagement Augsburg GmbH</name>
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        <city>Augsburg</city>
        <zip>86179</zip>
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  <location>
    <facility>
      <name>Klinikum Augsburg</name>
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        <city>Augsburg</city>
        <zip>86179</zip>
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  <location>
    <facility>
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        <city>Bad Bentheim</city>
        <zip>48455</zip>
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  <location>
    <facility>
      <name>Hautmedizin Bad Soden</name>
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        <city>Bad Soden am Taunus</city>
        <zip>65812</zip>
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    </facility>
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  <location>
    <facility>
      <name>Charite CCM, Dermatologie</name>
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        <city>Berlin</city>
        <zip>10117</zip>
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  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Im Friedrichshain</name>
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        <city>Berlin</city>
        <zip>10119</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Rothhaar Studien GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10783</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>ISA - Interdisciplinary Study Association GmbH</name>
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        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Berlin</city>
        <zip>12459</zip>
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    </facility>
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  <location>
    <facility>
      <name>Hautarztpraxis Dr.Wildfeuer</name>
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        <city>Berlin</city>
        <zip>13055</zip>
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      </address>
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  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Berlin</city>
        <zip>13597</zip>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Praxis 'Haut Pur'</name>
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        <city>Berlin</city>
        <zip>13597</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bielefeld Rosenhoehe</name>
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        <city>Bielefeld</city>
        <zip>33647</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Katholisches Klinikum Bochum gGmbH</name>
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        <city>Bochum</city>
        <zip>44791</zip>
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    </facility>
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  <location>
    <facility>
      <name>Niesmann &amp; Othlinghaus GbR</name>
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        <city>Bochum</city>
        <zip>44793</zip>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>MVZ Dermatologisches Zentrum Bonn GmbH</name>
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        <city>Bonn</city>
        <zip>53111</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Bonn</name>
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        <city>Bonn</city>
        <zip>53127</zip>
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    </facility>
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  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Borna</city>
        <zip>04552</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Bramsche</city>
        <zip>49565</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Derma Nord</name>
      <address>
        <city>Bremen</city>
        <zip>28779</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosenpark Research GmbH</name>
      <address>
        <city>Darmstadt</city>
        <zip>64283</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Darmstadt GmbH - Hautklinik</name>
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        <city>Darmstadt</city>
        <zip>64297</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Dresden GmbH</name>
      <address>
        <city>Dresden</city>
        <zip>01069</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Dermatologie und Venerologie</name>
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        <city>Dresden</city>
        <zip>01097</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Pro Derma</name>
      <address>
        <city>Duelmen</city>
        <zip>48249</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Privatpraxis Dr. Hilton &amp; Partner</name>
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        <city>Düsseldorf</city>
        <zip>40212</zip>
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    </facility>
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  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
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        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Erlangen</name>
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        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79104</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derma-Study-Center Friedrichshafen GmbH</name>
      <address>
        <city>Friedrichshafen</city>
        <zip>88045</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRH Waldklinikum Gera GmbH</name>
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        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis Brau/Groß</name>
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        <zip>35390</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen</name>
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        <city>Göttingen</city>
        <zip>37075</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20253</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatologikum Hamburg Gmbh</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCIderm GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20537</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MensingDerma research GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22391</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Die Hautklinik Hanau</name>
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        <city>Hanau</city>
        <zip>63450</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Haut- und Laserzentrum Heidelberg</name>
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        <city>Heidelberg</city>
        <zip>69115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg</name>
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        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis Offers/Adamini</name>
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        <city>Ibbenbüren</city>
        <zip>49477</zip>
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      </address>
    </facility>
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  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
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        <city>Jena</city>
        <zip>07745</zip>
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      </address>
    </facility>
  </location>
  <location>
    <facility>
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        <city>Kiel</city>
        <zip>24105</zip>
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      </address>
    </facility>
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  <location>
    <facility>
      <name>MVZ DermaKiel GmbH</name>
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        <city>Kiel</city>
        <zip>24148</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koeln</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Beate Schwarz - Germany</name>
      <address>
        <city>Langenau</city>
        <zip>89129</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig AÖR</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Lingen</city>
        <zip>49809</zip>
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  <location>
    <facility>
      <name>Otto Von Guericke Universität Magdeburg</name>
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        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Scholz/Sebastian/Schilling</name>
      <address>
        <city>Mahlow</city>
        <zip>15831</zip>
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  <location>
    <facility>
      <name>Hautarztzentrum am MDZ</name>
      <address>
        <city>Mainz</city>
        <zip>55128</zip>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Universitaetsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Memmingen</city>
        <zip>87700</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR</name>
      <address>
        <city>Moenchengladbach</city>
        <zip>41061</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universitaet Muenchen</name>
      <address>
        <city>Muenchen</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Osnabrück</name>
      <address>
        <city>Osnabrück</city>
        <zip>49074</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay</name>
      <address>
        <city>Quedlinburg</city>
        <zip>06484</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis Mortazawi</name>
      <address>
        <city>Remscheid</city>
        <zip>42897</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Schwerin GmbH</name>
      <address>
        <city>Schwerin</city>
        <zip>19055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Company for Medical Study &amp; Service Selters</name>
      <address>
        <city>Selters</city>
        <zip>56242</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis Dr. Leitz &amp; Kollegen</name>
      <address>
        <city>Stuttgart</city>
        <zip>70178</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis am Loewenmarkt</name>
      <address>
        <city>Stuttgart</city>
        <zip>70499</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
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        <zip>72076</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hautarztpraxis Kock</name>
      <address>
        <city>Vechta</city>
        <zip>49377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrovital</name>
      <address>
        <city>Witten</city>
        <zip>58453</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Wuppertal GmbH</name>
      <address>
        <city>Wuppertal</city>
        <zip>42283</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentroDerm GmbH</name>
      <address>
        <city>Wuppertal</city>
        <zip>42287</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>March 6, 2023</results_first_submitted>
  <results_first_submitted_qc>April 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2023</results_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03818035/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03818035/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Guselkumab 100 mg</title>
          <description>Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1.</description>
        </group>
        <group group_id="P2">
          <title>Group 2a: Guselkumab 100 mg Q8W</title>
          <description>Super responders (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 8 weeks (Q8W) dosing regimen starting at Week 28 till Week 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
        <group group_id="P3">
          <title>Group 2b: Guselkumab 100 mg Q16W</title>
          <description>Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 16 weeks (Q16W) dosing regimen at Weeks 36 and 52. To maintain the study blind, participants were administered placebo SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
        <group group_id="P4">
          <title>Group 2c: Guselkumab 100 mg Q8W</title>
          <description>Non-super responders (PASI score greater than [&gt;] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg SC injection Q8W dosing regimen starting at Week 28 till Week 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (Up to 28 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="880"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="823"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event - Worsening of Psoriasis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event - Other</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2 (Week 28 to Week 68)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="148">Only eligible participants from Part 1, were randomized into Part 2.</participants>
                <participants group_id="P3" count="150">Only eligible participants from Part 1, were randomized into Part 2.</participants>
                <participants group_id="P4" count="525">Only eligible participants from Part 1, entered into Part 2.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="148"/>
                <participants group_id="P3" count="149"/>
                <participants group_id="P4" count="525"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="137"/>
                <participants group_id="P3" count="142"/>
                <participants group_id="P4" count="496"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
              </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="6"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="9"/>
              </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="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Adverse Events</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Started Retreatment Phase Within Study Part 2</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_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="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population for Part 1 included all participants who were treated with at least one dose of study in Part 1.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Guselkumab 100 mg</title>
          <description>Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="880"/>
          </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="803"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </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="42.5" spread="14.7"/>
                  </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="260"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="859"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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>FRANCE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERMANY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (&lt;) 3 at Week 68</title>
        <description>Percentage of participants who achieved an absolute PASI &lt;3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percentage [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.</description>
        <time_frame>Week 68</time_frame>
        <population>ITT population for Part 2 (Group 2a and Group 2b) included all randomized participants at week 28. Here, 'N' (Overall number of participants) signifies participants who continued study treatment in Part 2 with blinded study drug (randomized Groups 2a and 2b) or with open label study drug (Group 2c).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 2a: Guselkumab 100 mg Q8W</title>
            <description>Super responders (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 8 weeks (Q8W) dosing regimen starting at Week 28 till Week 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
          </group>
          <group group_id="O2">
            <title>Group 2b: Guselkumab 100 mg Q16W</title>
            <description>Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 16 weeks (Q16W) dosing regimen at Weeks 36 and 52. To maintain the study blind, participants were administered placebo SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
          </group>
        </group_list>
        <measure>
          <title>Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (&lt;) 3 at Week 68</title>
          <description>Percentage of participants who achieved an absolute PASI &lt;3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percentage [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.</description>
          <population>ITT population for Part 2 (Group 2a and Group 2b) included all randomized participants at week 28. Here, 'N' (Overall number of participants) signifies participants who continued study treatment in Part 2 with blinded study drug (randomized Groups 2a and 2b) or with open label study drug (Group 2c).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.6" lower_limit="88.0" upper_limit="95.8"/>
                    <measurement group_id="O2" value="91.9" lower_limit="87.3" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.</non_inferiority_desc>
            <p_value>0.0013</p_value>
            <method>Wald Z-test</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Improvement From Baseline (Week 0) in PASI Score</title>
        <description>Time to improvement from baseline in PASI (PASI 75/90/100 response and absolute PASI score =0) for participants with short disease duration (SDD) (less than or equal to [&lt;=] 2 years) and longer disease duration (LDD) (greater than [&gt;] 2 years) was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75/90/100 responders were defined as participants with &gt;= 75%, &gt;= 90%, 100% improvement in PASI respectively.</description>
        <time_frame>Group 1: Week 0 up to Week 28; Group 2a, 2b, 2c: Week 28 up to Week 68</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, &lt;=1 and &lt;3 at Weeks 20, 28, 68, 116, 164 and 120</title>
        <description>Percentage of participants with short (&lt;=2 years) and longer (&gt;2 years) disease duration who achieved an absolute PASI Score of 0, &lt;=1 and less than (&lt;) 3 will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
        <time_frame>Weeks 20, 28, 68, 116, 164 and 120</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score &lt; 3)</title>
        <description>Percentage of participants who retain disease control (that is, absolute PASI score &lt;3 from week 68 through week 116 for participants with short (&lt;= 2 years) and longer (&gt;2 years) disease duration will be reported. Control of disease was defined as participants with a PASI score &lt;3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease</description>
        <time_frame>Week 68 up to Week 116</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220</title>
        <description>Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with &gt;= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with &gt;= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.</description>
        <time_frame>Weeks 20, 28, 68, 116, 164, and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score &gt;5) After Treatment Withdrawal</title>
        <description>Time to loss of disease control (absolute PASI score &gt;5) after treatment withdrawal beyond Week 68 up to Week 116 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
        <time_frame>Week 68 up to Week 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28</title>
        <description>Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
        <time_frame>Weeks 12, 16, 20 and 28</time_frame>
        <population>ITT population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Guselkumab 100 mg</title>
            <description>Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28</title>
          <description>Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
          <population>ITT population included all randomized participants.</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="880"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220</title>
        <description>Change from baseline (Week 0) in DLQI score at Weeks 28, 68, 116, 164 and 220 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.</description>
        <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and &lt;5</title>
        <description>Percentage of participants who achieved a DLQI score 0/1 and &lt;5 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.</description>
        <time_frame>Weeks 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220</title>
        <description>Change from baseline in the psoriasis affected BSA (%) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220 will be reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA).</description>
        <time_frame>Baseline (Week 0), Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220</title>
        <description>Change from baseline in NAPPA-QOL at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-QOL was a 20-item nail-specific QoL questionnaire covering past week. Signs, stigma and everyday life were rated on a 5-point scale, ranged from 0 (no suffering) to 4 (high suffering). A global score was computed by averaging all items which ranged from 0 (no suffering) to 4 (high suffering). A decrease in NAPPA QoL score indicated improvement.</description>
        <time_frame>Baseline (Week 0), 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220</title>
        <description>Change from baseline in NAPPA-PBI at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-PBI was a 24-item questionnaire to assess participant-defined needs before and participant-rated benefits after treatment. The answers were given on a scale from 0 to 4, and a global score was calculated as follows: Each benefit item was multiplied with the respective importance item, and the product is divided by the sum of all importance items. The results were summed up over all items. The resulting global score ranged from 0 (no benefit) to 4 (highest possible benefit). Higher score indicated more benefit.</description>
        <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220</title>
        <description>Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.</description>
        <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220</title>
        <description>Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of &gt;= 40 points in PSSD symptom score or sign score, and a &gt;= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).</description>
        <time_frame>Baseline (Week 0), Weeks 28, 68, 116, 164 and 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score &gt;= 1 at Week 28</title>
        <description>Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score &gt;= 1 at Week 28 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of &gt;= 40 points in PSSD symptom score or sign score, and a &gt;= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).</description>
        <time_frame>Week 68</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level</title>
        <description>The potential association between trough serum guselkumab concentration and efficacy or serum biomarker level will be analyzed by immunoassays. For the analyses the trough serum guselkumab concentration will be set into relation with the efficacy (e.g. PASI response) or with serum biomarker (e.g. serum IL-17A, IL-17F, IL-22) concentration. Guselkumab and all biomarker concentrations will be measured in the unit of picogram/milliliter (pg/mL). In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.</description>
        <time_frame>Up to Week 80</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score &lt;3 at Week 68</title>
        <description>The potential association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score &lt;3 at Week 68 will be analyzed. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.</description>
        <time_frame>Weeks 20, 28, 36, 68</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI &gt;5) and Regain Control of Disease (PASI &lt;3) 24 Weeks After Start of Re-Treatment</title>
        <description>Percentage of participants who were re-treated due to loss of disease control (PASI &gt;5) and regain control of disease (PASI &lt;3) 24 Weeks after start of re-treatment will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.</description>
        <time_frame>Start of re-treatment up to 24 weeks</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.</description>
        <time_frame>Up to Week 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities</title>
        <description>Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) were reported.</description>
        <time_frame>Week 220</time_frame>
        <posting_date>01/2026</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Part 1: Up to Week 28; Part 2: from Week 28 up to Week 72</time_frame>
      <desc>Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: Guselkumab 100 mg</title>
          <description>Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1.</description>
        </group>
        <group group_id="E2">
          <title>Group 2a: Guselkumab 100 mg Q8W</title>
          <description>Super responders (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 8 weeks (Q8W) dosing regimen starting at Week 28 till Week 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
        <group group_id="E3">
          <title>Group 2b: Guselkumab 100 mg Q16W</title>
          <description>Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg SC injection every 16 weeks (Q16W) dosing regimen at Weeks 36 and 52. To maintain the study blind, participants were administered placebo SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
        <group group_id="E4">
          <title>Group 2c: Guselkumab 100 mg Q8W</title>
          <description>Non-super responders (PASI score greater than [&gt;] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg SC injection Q8W dosing regimen starting at Week 28 till Week 60. Participants were followed from Week 28 till Week 68 or early termination prior to Week 68.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 24.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Splenic Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis Coronary Artery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </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="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Autoimmune Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess of External Auditory Meatus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bacterial Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chronic Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infectious Mononucleosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peritonsillar Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Procedural Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tooth Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bone Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cartilage Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ligament Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lumbar Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Procedural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Traumatic Liver Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </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="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </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="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Spinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Benign Hepatic Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Colorectal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma of Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tumour Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nerve Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pseudoradicular Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Suicidal Behaviour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypersensitivity Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Extremity Necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertensive Urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 24.1</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="631" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="103" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="367" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Spontaneous Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aortic Valve Sclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aortic Valve Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cardiac Perfusion Defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cardiovascular Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Heart Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Left Ventricular Hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Supraventricular Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Epidermal Naevus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gilbert's Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Conductive Deafness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Excessive Cerumen Production</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sudden Hearing Loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Androgen Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperprolactinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Borderline Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Conjunctival Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Conjunctivitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dry Eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eczema Eyelids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eye Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ocular Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ocular Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ocular Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Optic Nerve Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Retinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ulcerative Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Visual Acuity Reduced</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Anal Fissure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aphthous Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dental Caries</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dental Necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diverticulum Intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Epigastric Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erosive Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Faeces Soft</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastric Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Polyp Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gingival Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haemorrhoids Thrombosed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hiatus Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Paraesthesia Oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tongue Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse Drug Reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Application Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Drug Ineffective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Foreign Body Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Induration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Scar</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Localised Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Temperature Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vaccination Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vaccination Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary Colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to Arthropod Bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Anaphylactic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Contrast Media Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Food Allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Mite Allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Seasonal Allergy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abscess Jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Abscess Oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Acne Pustular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bacterial Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Balanitis Candida</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Body Tinea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Borrelia Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bronchitis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Candida Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chronic Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Coronavirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diabetic Foot Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eczema Infected</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Enteritis Infectious</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erythema Migrans</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fungal Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fungal Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer Helicobacter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Infection</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Genital Herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Genital Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Genital Infection Fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hantaviral Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Helicobacter Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Herpes Simplex</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Herpes Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infected Bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infected Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infected Dermal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infected Skin Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infectious Mononucleosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Infective Glossitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lyme Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Malassezia Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nail Bed Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasal Herpes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="214" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="97" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oesophageal Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oral Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oral Fungal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Otitis Media Viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pelvic Inflammatory Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peritonsillar Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pulpitis Dental</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Root Canal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Scarlet Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Bacterial Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Candida</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Subcutaneous Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinea Cruris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinea Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinea Manuum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinea Pedis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tinea Versicolour</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tonsillitis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tooth Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urethritis Gonococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vaginal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Viral Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Mycotic Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Arthropod Bite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Arthropod Sting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bone Contusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Burns Second Degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Burns Third Degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chillblains</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Corneal Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eye Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibula Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Foreign Body in Eye</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fractured Coccyx</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hand Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Heat Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Human Bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Inappropriate Schedule of Product Administration</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Incision Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Incomplete Spinal Fusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Joint Capsule Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Joint Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Joint Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lower Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lumbar Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Meniscus Injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Muscle Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Procedural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Procedural Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Procedural Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post-Traumatic Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Procedural Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tendon Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tooth Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Traumatic Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urinary Retention Postoperative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vaccination Complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aortic Bruit</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Basophil Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bilirubin Conjugated Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Unconjugated Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Cholesterol Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Creatine Phosphokinase Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Glucose Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Lactate Dehydrogenase Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Potassium Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Potassium Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Triglycerides Increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Urea Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blood Uric Acid Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cardiac Murmur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haematocrit Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Heart Rate Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lipids Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Liver Function Test Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lymphocyte Morphology Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Platelet Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prostatic Specific Antigen Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Spermatozoa Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Streptococcus Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Transaminases Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tri-Iodothyronine Free Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fat Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypovitaminosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Selenium Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vitamin B12 Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vitamin D Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Weight Fluctuation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </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="41" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chondropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Enthesopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Joint Stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Joint Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Limb Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Muscle Tightness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nodal Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Plantar Fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Polymyalgia Rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Psoriatic Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sacral Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Scoliosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Spinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Spinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tendon Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Trigger Finger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acanthoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Anogenital Warts</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Benign Hepatic Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Benign Neoplasm of Adrenal Gland</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Benign Neoplasm of Eyelid</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dysplastic Naevus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of Breast</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Fibrous Histiocytoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Melanocytic Naevus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Osteoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Seborrhoeic Keratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Papilloma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma of Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Carpal Tunnel Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cervicobrachial Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cubital Tunnel Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Disturbance in Attention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dizziness Postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Facial Paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Gliosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Head Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Migraine with Aura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nerve Compression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neuritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Neuropathy Vitamin B6 Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Orthostatic Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peripheral Nerve Lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Post Herpetic Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Precerebral Arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pseudoradicular Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Restless Legs Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thoracic Outlet Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thoracic Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Burnout Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Depressive Symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Panic Attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Personality Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sleep Disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sleep Disorder Due to A General Medical Condition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Suicidal Behaviour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urethral Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </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="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erectile Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Ovarian Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Heavy Menstrual Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Menopausal Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Menstruation Irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Ovarian Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Polycystic Ovaries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pruritus Genital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Testicular Torsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Respiratory Symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Allergic Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypersensitivity Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Increased Upper Airway Secretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Larynx Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasal Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nasal Septum Deviation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Painful Respiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rhinitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Sleep Apnoea Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Tonsillar Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Upper Airway Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Actinic Keratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Chloasma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dermal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dermatitis Psoriasiform</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Drug Eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Dyshidrotic Eczema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eczema Asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Eczema Nummular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erythema Nodosum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Erythrodermic Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Koebner Phenomenon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nail Dystrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Nail Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Night Sweats</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Perioral Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Photosensitivity Reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pityriasis Rosea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Polymorphic Light Eruption</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Prurigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Seborrhoeic Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Burning Sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Fissures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Fragility</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Induration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Maceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Texture Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Solar Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Stasis Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Toxic Skin Eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urticaria Contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Urticaria Physical</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Extremity Necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Hypertensive Urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Peripheral Venous Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>Varicose Vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="525"/>
              </event>
              <event>
                <sub_title>White Coat Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="880"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="148"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="525"/>
              </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>If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>As per change in the planned analysis Group 2d analysis was not performed, analysis of corresponding secondary endpoints has been postponed to avoid delay of study Part 2 analysis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>GUIDE-Study Responsible Physician</name_or_title>
      <organization>Janssen Research &amp; Development LLC</organization>
      <phone>844-434-4210</phone>
      <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/NCT03818035
org study id: CR108514
secondary id: 2018-001238-16
secondary id: CNTO1959PSO3012
nct id: NCT03818035
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis
      participants who receive on-label guselkumab treatment until week 20 and respond with a
      Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of
      disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every
      16 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
time frame: Week 68
description: Percentage of participants who achieved an absolute PASI <3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percentage [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
measure: Time to Improvement From Baseline (Week 0) in PASI Score
time frame: Group 1: Week 0 up to Week 28; Group 2a, 2b, 2c: Week 28 up to Week 68
description: Time to improvement from baseline in PASI (PASI 75/90/100 response and absolute PASI score =0) for participants with short disease duration (SDD) (less than or equal to [<=] 2 years) and longer disease duration (LDD) (greater than [>] 2 years) was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75/90/100 responders were defined as participants with >= 75%, >= 90%, 100% improvement in PASI respectively.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 120
time frame: Weeks 20, 28, 68, 116, 164 and 120
description: Percentage of participants with short (<=2 years) and longer (>2 years) disease duration who achieved an absolute PASI Score of 0, <=1 and less than (<) 3 will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
measure: Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3)
time frame: Week 68 up to Week 116
description: Percentage of participants who retain disease control (that is, absolute PASI score <3 from week 68 through week 116 for participants with short (<= 2 years) and longer (>2 years) disease duration will be reported. Control of disease was defined as participants with a PASI score <3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
time frame: Weeks 20, 28, 68, 116, 164, and 220
description: Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with >= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with >= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.
measure: Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal
time frame: Week 68 up to Week 220
description: Time to loss of disease control (absolute PASI score >5) after treatment withdrawal beyond Week 68 up to Week 116 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
measure: Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
time frame: Weeks 12, 16, 20 and 28
description: Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220
time frame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
description: Change from baseline (Week 0) in DLQI score at Weeks 28, 68, 116, 164 and 220 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
time frame: Weeks 28, 68, 116, 164 and 220
description: Percentage of participants who achieved a DLQI score 0/1 and <5 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
measure: Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220
time frame: Baseline (Week 0), Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220
description: Change from baseline in the psoriasis affected BSA (%) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220 will be reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA).
measure: Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220
time frame: Baseline (Week 0), 28, 68, 116, 164 and 220
description: Change from baseline in NAPPA-QOL at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-QOL was a 20-item nail-specific QoL questionnaire covering past week. Signs, stigma and everyday life were rated on a 5-point scale, ranged from 0 (no suffering) to 4 (high suffering). A global score was computed by averaging all items which ranged from 0 (no suffering) to 4 (high suffering). A decrease in NAPPA QoL score indicated improvement.
measure: Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220
time frame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
description: Change from baseline in NAPPA-PBI at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-PBI was a 24-item questionnaire to assess participant-defined needs before and participant-rated benefits after treatment. The answers were given on a scale from 0 to 4, and a global score was calculated as follows: Each benefit item was multiplied with the respective importance item, and the product is divided by the sum of all importance items. The results were summed up over all items. The resulting global score ranged from 0 (no benefit) to 4 (highest possible benefit). Higher score indicated more benefit.
measure: Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
time frame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
description: Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
time frame: Baseline (Week 0), Weeks 28, 68, 116, 164 and 220
description: Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).
measure: Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28
time frame: Week 68
description: Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score >= 1 at Week 28 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).
measure: Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level
time frame: Up to Week 80
description: The potential association between trough serum guselkumab concentration and efficacy or serum biomarker level will be analyzed by immunoassays. For the analyses the trough serum guselkumab concentration will be set into relation with the efficacy (e.g. PASI response) or with serum biomarker (e.g. serum IL-17A, IL-17F, IL-22) concentration. Guselkumab and all biomarker concentrations will be measured in the unit of picogram/milliliter (pg/mL). In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
measure: Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score <3 at Week 68
time frame: Weeks 20, 28, 36, 68
description: The potential association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score <3 at Week 68 will be analyzed. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.
measure: Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment
time frame: Start of re-treatment up to 24 weeks
description: Percentage of participants who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 Weeks after start of re-treatment will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Up to Week 220
description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
measure: Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities
time frame: Week 220
description: Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) were reported.
arm group label: Part 1: Guselkumab
arm group type: Experimental
description: Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.
arm group label: Part 2: Guselkumab q8w and Guselkumab q16w
arm group type: Experimental
description: Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder [SRe]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score >5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16.
arm group label: Part 2: Guselkumab q8w
arm group type: Experimental
description: Participants (Non SRe) in group 2c with a PASI score greater than (>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.
arm group label: Part 3: Guselkumab Withdrawal
arm group type: Experimental
description: Participants from groups 2a and 2b with a PASI score <3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to [>=] 3) at week 68 or PASI >5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w.
intervention type: Drug
intervention name: Guselkumab
description: Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
arm group label: Part 1: Guselkumab
arm group label: Part 2: Guselkumab q8w
arm group label: Part 2: Guselkumab q8w and Guselkumab q16w
arm group label: Part 3: Guselkumab Withdrawal
other name: TREMFYA
intervention type: Drug
intervention name: Placebo Injection
description: Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
arm group label: Part 2: Guselkumab q8w
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
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country: France
country: Germany
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: As per change in the planned analysis Group 2d analysis was not performed, analysis of corresponding secondary endpoints has been postponed to avoid delay of study Part 2 analysis.
point of contact: 