<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/NCT02980692</url>
  </required_header>
  <id_info>
    <org_study_id>CLR_16_23</org_study_id>
    <nct_id>NCT02980692</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SUNPG1623</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to&#xD;
      demonstrate the safety and efficacy of SUNPG1623&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">September 24, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</measure>
    <time_frame>week 24</time_frame>
    <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</measure>
    <time_frame>week 52</time_frame>
    <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving American College of Rheumatology50 Response Rate</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52</time_frame>
    <description>The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving American College of Rheumatology70 Response Rate</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52</time_frame>
    <description>The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender Joint Counts</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender Joint Counts</measure>
    <time_frame>Week 52</time_frame>
    <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Counts</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Counts</measure>
    <time_frame>Week 52</time_frame>
    <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment of Disease Activity Visual Analog Scale</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale</measure>
    <time_frame>Week 52</time_frame>
    <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Global Assessment of Disease Activity</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20 and week 24</time_frame>
    <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Global Assessment of Disease Activity</measure>
    <time_frame>Week 52</time_frame>
    <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Pain Assessment</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Pain Assessment</measure>
    <time_frame>Week 52</time_frame>
    <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire- Disability Index</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire- Disability Index</measure>
    <time_frame>Week 52</time_frame>
    <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Phase C - Reactive Protein</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Phase C - Reactive Protein</measure>
    <time_frame>Week 52</time_frame>
    <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.&#xD;
Change from Baseline in C-Reactive Protein.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte Sedimentation Rate</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
    <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Sedimentation Rate</measure>
    <time_frame>Week 52</time_frame>
    <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Subjects Who Require Adjustment of Background Therapy</measure>
    <time_frame>Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52</time_frame>
    <description>The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).&#xD;
DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal Disease Activity</measure>
    <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52</time_frame>
    <description>A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:&#xD;
tender joint count ≤1;&#xD;
swollen joint count ≤1;&#xD;
PASI score ≤1 or BSA ≤3%;&#xD;
patient Arthritis Pain (VAS)&#xD;
≤15 mm;&#xD;
patient's global arthritis assessment (VAS) ≤20 mm;&#xD;
HAQ-DI score ≤0.5;&#xD;
tender entheseal points (using LEI) ≤1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Dactylitis Index (LDI)</measure>
    <time_frame>week 4, week 12, and week 24</time_frame>
    <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Dactylitis Index (LDI)</measure>
    <time_frame>Week 52</time_frame>
    <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Enthesitis Index (LEI)</measure>
    <time_frame>week 4, week 12 and week 24</time_frame>
    <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Leeds Enthesitis Index (LEI)</measure>
    <time_frame>Week 52</time_frame>
    <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">391</enrollment>
  <condition>Active Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>SUNPG1623 dose I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low range dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SUNPG1623 dose II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mid range dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SUNPG1623 dose III</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mid range dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SUNPG1623 dose IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mid range dose to high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>mid range dose to high dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUNPG1623 I</intervention_name>
    <description>injection</description>
    <arm_group_label>SUNPG1623 dose I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUNPG1623 II</intervention_name>
    <description>injection</description>
    <arm_group_label>SUNPG1623 dose II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUNPG1623 III</intervention_name>
    <description>injection</description>
    <arm_group_label>SUNPG1623 dose III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUNPG1623 IV</intervention_name>
    <description>injection</description>
    <arm_group_label>SUNPG1623 dose IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLACEBO</intervention_name>
    <description>injection</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>SUNPG1623 dose II</arm_group_label>
    <arm_group_label>SUNPG1623 dose III</arm_group_label>
    <arm_group_label>SUNPG1623 dose IV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided written informed consent&#xD;
&#xD;
          -  Subject is ≥ 18 years of age at time of Screening&#xD;
&#xD;
          -  Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP&#xD;
&#xD;
          -  Subject has a negative evaluation for TB within 4 weeks before initiating IMP&#xD;
&#xD;
          -  Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR]&#xD;
             criteria) with symptoms present for at least 6 months.&#xD;
&#xD;
          -  Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a planned surgical intervention between Baseline and the Week 24&#xD;
             evaluation for a pretreatment condition&#xD;
&#xD;
          -  Subject has an active infection or history of infections&#xD;
&#xD;
          -  Subject has any concurrent medical condition or uncontrolled, clinically significant&#xD;
             systemic disease&#xD;
&#xD;
          -  Subject has a known history of infection with hepatitis B, hepatitis C, or human&#xD;
             immunodeficiency virus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SPARC Site 1</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>October 3, 2020</results_first_submitted>
  <results_first_submitted_qc>May 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 19, 2021</results_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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>March 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02980692/Prot_002.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>October 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02980692/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SUNPG1623 I</title>
          <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
        </group>
        <group group_id="P2">
          <title>SUNPG1623 II</title>
          <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="P3">
          <title>SUNPG1623 Dose III</title>
          <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="P4">
          <title>SUNPG1623 Dose IV</title>
          <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="P5">
          <title>Placebo</title>
          <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind Placebo Controlled Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="78"/>
                <participants group_id="P5" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="60"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to show sufficient response to treatment at Week 24</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double-blind Follow-up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="60"/>
                <participants group_id="P4" count="71"/>
                <participants group_id="P5" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="67"/>
                <participants group_id="P5" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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="4"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to show sufficient response to treatment at Week 24</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SUNPG1623 I</title>
          <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
        </group>
        <group group_id="B2">
          <title>SUNPG1623 II</title>
          <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="B3">
          <title>SUNPG1623 Dose III</title>
          <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="B4">
          <title>SUNPG1623 Dose IV</title>
          <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="B5">
          <title>Placebo</title>
          <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="78"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="77"/>
            <count group_id="B4" value="78"/>
            <count group_id="B5" value="79"/>
            <count group_id="B6" value="391"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.1" spread="13.28"/>
                    <measurement group_id="B2" value="49.3" spread="11.24"/>
                    <measurement group_id="B3" value="49.2" spread="11.85"/>
                    <measurement group_id="B4" value="47.2" spread="13.35"/>
                    <measurement group_id="B5" value="48.1" spread="13.30"/>
                    <measurement group_id="B6" value="48.8" spread="12.61"/>
                  </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="46"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="44"/>
                    <measurement group_id="B6" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="35"/>
                    <measurement group_id="B6" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="68"/>
                    <measurement group_id="B6" value="332"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="75"/>
                    <measurement group_id="B5" value="74"/>
                    <measurement group_id="B6" value="378"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</title>
        <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
        <time_frame>week 24</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of ACR20 Response Rate At Week 24 (Missing Response = Non-response) - Primary Analysis (Full Analysis Set)</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</title>
          <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
          <population>Cochran-Mantel-Haenszel Analysis of ACR20 Response Rate At Week 24 (Missing Response = Non-response) - Primary Analysis (Full Analysis Set)</population>
          <units>proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7949"/>
                    <measurement group_id="O2" value="0.7722"/>
                    <measurement group_id="O3" value="0.7143"/>
                    <measurement group_id="O4" value="0.7308"/>
                    <measurement group_id="O5" value="0.5063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0088</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0041</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</title>
        <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
        <time_frame>week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate</title>
          <description>The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
          <population>Full Analysis Set</population>
          <units>proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="75"/>
                <count group_id="O5" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9254"/>
                    <measurement group_id="O2" value="0.8906"/>
                    <measurement group_id="O3" value="0.8667"/>
                    <measurement group_id="O4" value="0.8133"/>
                    <measurement group_id="O5" value="0.8133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>92.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>86.24</ci_lower_limit>
            <ci_upper_limit>98.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>89.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.90</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.42</ci_lower_limit>
            <ci_upper_limit>96.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>86.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>78.07</ci_lower_limit>
            <ci_upper_limit>95.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>81.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72.52</ci_lower_limit>
            <ci_upper_limit>90.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>81.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>72.52</ci_lower_limit>
            <ci_upper_limit>90.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving American College of Rheumatology50 Response Rate</title>
        <description>The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set.&#xD;
ACR50 Response Rates up to Week 52 Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving American College of Rheumatology50 Response Rate</title>
          <description>The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
          <population>Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set.&#xD;
ACR50 Response Rates up to Week 52 Full Analysis Set.</population>
          <units>proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.0253"/>
                    <measurement group_id="O3" value="0.0130"/>
                    <measurement group_id="O4" value="0.0128"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0256"/>
                    <measurement group_id="O2" value="0.0506"/>
                    <measurement group_id="O3" value="0.0909"/>
                    <measurement group_id="O4" value="0.0385"/>
                    <measurement group_id="O5" value="0.0253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1667"/>
                    <measurement group_id="O2" value="0.0759"/>
                    <measurement group_id="O3" value="0.1299"/>
                    <measurement group_id="O4" value="0.1410"/>
                    <measurement group_id="O5" value="0.0759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1795"/>
                    <measurement group_id="O2" value="0.1772"/>
                    <measurement group_id="O3" value="0.2078"/>
                    <measurement group_id="O4" value="0.1923"/>
                    <measurement group_id="O5" value="0.0633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3077"/>
                    <measurement group_id="O2" value="0.2785"/>
                    <measurement group_id="O3" value="0.2727"/>
                    <measurement group_id="O4" value="0.2051"/>
                    <measurement group_id="O5" value="0.0506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4487"/>
                    <measurement group_id="O2" value="0.4177"/>
                    <measurement group_id="O3" value="0.2857"/>
                    <measurement group_id="O4" value="0.2308"/>
                    <measurement group_id="O5" value="0.1646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5256"/>
                    <measurement group_id="O2" value="0.5063"/>
                    <measurement group_id="O3" value="0.4545"/>
                    <measurement group_id="O4" value="0.3974"/>
                    <measurement group_id="O5" value="0.2405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="75"/>
                    <count group_id="O5" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7910"/>
                    <measurement group_id="O2" value="0.7500"/>
                    <measurement group_id="O3" value="0.7213"/>
                    <measurement group_id="O4" value="0.6800"/>
                    <measurement group_id="O5" value="0.6267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>79.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>69.37</ci_lower_limit>
            <ci_upper_limit>88.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>75.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>64.39</ci_lower_limit>
            <ci_upper_limit>85.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>72.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.74</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.88</ci_lower_limit>
            <ci_upper_limit>83.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>68.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>57.44</ci_lower_limit>
            <ci_upper_limit>78.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>62.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>51.72</ci_lower_limit>
            <ci_upper_limit>73.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving American College of Rheumatology70 Response Rate</title>
        <description>The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set ACR70 Response Rates up to Week 52 Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving American College of Rheumatology70 Response Rate</title>
          <description>The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.&#xD;
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.</description>
          <population>Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set ACR70 Response Rates up to Week 52 Full Analysis Set.</population>
          <units>proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.0127"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0128"/>
                    <measurement group_id="O2" value="0.0127"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.0128"/>
                    <measurement group_id="O5" value="0.0127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0256"/>
                    <measurement group_id="O2" value="0.0380"/>
                    <measurement group_id="O3" value="0.0260"/>
                    <measurement group_id="O4" value="0.0256"/>
                    <measurement group_id="O5" value="0.0380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1026"/>
                    <measurement group_id="O2" value="0.0380"/>
                    <measurement group_id="O3" value="0.0649"/>
                    <measurement group_id="O4" value="0.1026"/>
                    <measurement group_id="O5" value="0.0127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1410"/>
                    <measurement group_id="O2" value="0.1266"/>
                    <measurement group_id="O3" value="0.1169"/>
                    <measurement group_id="O4" value="0.0897"/>
                    <measurement group_id="O5" value="0.0253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2051"/>
                    <measurement group_id="O2" value="0.2658"/>
                    <measurement group_id="O3" value="0.1429"/>
                    <measurement group_id="O4" value="0.1282"/>
                    <measurement group_id="O5" value="0.0380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2821"/>
                    <measurement group_id="O2" value="0.2911"/>
                    <measurement group_id="O3" value="0.2208"/>
                    <measurement group_id="O4" value="0.1667"/>
                    <measurement group_id="O5" value="0.1013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="75"/>
                    <count group_id="O5" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5821"/>
                    <measurement group_id="O2" value="0.4844"/>
                    <measurement group_id="O3" value="0.3934"/>
                    <measurement group_id="O4" value="0.4000"/>
                    <measurement group_id="O5" value="0.3733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>58.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.40</ci_lower_limit>
            <ci_upper_limit>70.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>48.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>36.19</ci_lower_limit>
            <ci_upper_limit>60.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>39.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.09</ci_lower_limit>
            <ci_upper_limit>51.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>40.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.91</ci_lower_limit>
            <ci_upper_limit>51.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>37.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.39</ci_lower_limit>
            <ci_upper_limit>48.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender Joint Counts</title>
        <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender Joint Counts</title>
          <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
          <units>tender joint counts</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.77"/>
                    <measurement group_id="O2" value="-2.4" spread="0.76"/>
                    <measurement group_id="O3" value="-2.5" spread="0.78"/>
                    <measurement group_id="O4" value="-3.1" spread="0.76"/>
                    <measurement group_id="O5" value="-2.1" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="0.89"/>
                    <measurement group_id="O2" value="-4.9" spread="0.88"/>
                    <measurement group_id="O3" value="-5.4" spread="0.89"/>
                    <measurement group_id="O4" value="-3.9" spread="0.88"/>
                    <measurement group_id="O5" value="-4.1" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="0.94"/>
                    <measurement group_id="O2" value="-7.8" spread="0.92"/>
                    <measurement group_id="O3" value="-8.6" spread="0.94"/>
                    <measurement group_id="O4" value="-7.2" spread="0.93"/>
                    <measurement group_id="O5" value="-6.9" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="0.96"/>
                    <measurement group_id="O2" value="-10.0" spread="0.94"/>
                    <measurement group_id="O3" value="-8.7" spread="0.95"/>
                    <measurement group_id="O4" value="-7.8" spread="0.96"/>
                    <measurement group_id="O5" value="-7.7" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" spread="1.04"/>
                    <measurement group_id="O2" value="-11.3" spread="1.01"/>
                    <measurement group_id="O3" value="-10.7" spread="1.03"/>
                    <measurement group_id="O4" value="-9.8" spread="1.04"/>
                    <measurement group_id="O5" value="-8.4" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" spread="1.09"/>
                    <measurement group_id="O2" value="-12.3" spread="1.06"/>
                    <measurement group_id="O3" value="-11.5" spread="1.07"/>
                    <measurement group_id="O4" value="-11.4" spread="1.09"/>
                    <measurement group_id="O5" value="-9.9" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.9" spread="1.04"/>
                    <measurement group_id="O2" value="-12.6" spread="1.01"/>
                    <measurement group_id="O3" value="-12.9" spread="1.03"/>
                    <measurement group_id="O4" value="-12.0" spread="1.04"/>
                    <measurement group_id="O5" value="-9.4" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0850</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0234</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0140</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0731</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender Joint Counts</title>
        <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender Joint Counts</title>
          <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
          <population>Full Analysis Set</population>
          <units>tender joint counts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" spread="11.47"/>
                    <measurement group_id="O2" value="-13.7" spread="11.92"/>
                    <measurement group_id="O3" value="-16.0" spread="12.83"/>
                    <measurement group_id="O4" value="-14.0" spread="10.65"/>
                    <measurement group_id="O5" value="-13.9" spread="12.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-12.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>11.47</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-13.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>11.92</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-16.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>12.83</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-14.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.65</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-13.9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>12.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Counts</title>
        <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Counts</title>
          <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>Swollen Joint Counts</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.51"/>
                    <measurement group_id="O2" value="-2.1" spread="0.51"/>
                    <measurement group_id="O3" value="-1.3" spread="0.52"/>
                    <measurement group_id="O4" value="-2.4" spread="0.51"/>
                    <measurement group_id="O5" value="-1.3" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="0.56"/>
                    <measurement group_id="O2" value="-3.8" spread="0.55"/>
                    <measurement group_id="O3" value="-3.8" spread="0.56"/>
                    <measurement group_id="O4" value="-3.0" spread="0.55"/>
                    <measurement group_id="O5" value="-3.1" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="0.55"/>
                    <measurement group_id="O2" value="-5.5" spread="0.54"/>
                    <measurement group_id="O3" value="-5.7" spread="0.55"/>
                    <measurement group_id="O4" value="-5.0" spread="0.55"/>
                    <measurement group_id="O5" value="-4.7" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="0.55"/>
                    <measurement group_id="O2" value="-6.6" spread="0.54"/>
                    <measurement group_id="O3" value="-6.2" spread="0.55"/>
                    <measurement group_id="O4" value="-4.8" spread="0.55"/>
                    <measurement group_id="O5" value="-4.9" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="0.56"/>
                    <measurement group_id="O2" value="-7.2" spread="0.55"/>
                    <measurement group_id="O3" value="-7.0" spread="0.55"/>
                    <measurement group_id="O4" value="-6.0" spread="0.56"/>
                    <measurement group_id="O5" value="-5.2" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="0.56"/>
                    <measurement group_id="O2" value="-7.4" spread="0.55"/>
                    <measurement group_id="O3" value="-7.4" spread="0.56"/>
                    <measurement group_id="O4" value="-6.8" spread="0.56"/>
                    <measurement group_id="O5" value="-6.0" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="0.52"/>
                    <measurement group_id="O2" value="-7.7" spread="0.51"/>
                    <measurement group_id="O3" value="-8.2" spread="0.52"/>
                    <measurement group_id="O4" value="-7.6" spread="0.52"/>
                    <measurement group_id="O5" value="-6.5" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0111</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0774</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0190</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1282</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Counts</title>
        <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Counts</title>
          <description>Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.</description>
          <population>Full Analysis Set</population>
          <units>Swollen Joint Counts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="6.88"/>
                    <measurement group_id="O2" value="-7.5" spread="7.07"/>
                    <measurement group_id="O3" value="-9.2" spread="7.62"/>
                    <measurement group_id="O4" value="-7.5" spread="5.78"/>
                    <measurement group_id="O5" value="-9.0" spread="8.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-8.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>6.88</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7.5</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>7.07</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>7.62</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7.5</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>5.78</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>8.80</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Global Assessment of Disease Activity Visual Analog Scale</title>
        <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment of Disease Activity Visual Analog Scale</title>
          <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
          <units>scores on a visual analog scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="1.69"/>
                    <measurement group_id="O2" value="-8.0" spread="1.68"/>
                    <measurement group_id="O3" value="-7.2" spread="1.70"/>
                    <measurement group_id="O4" value="-6.2" spread="1.68"/>
                    <measurement group_id="O5" value="-4.5" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.3" spread="2.01"/>
                    <measurement group_id="O2" value="-15.7" spread="1.99"/>
                    <measurement group_id="O3" value="-15.1" spread="1.99"/>
                    <measurement group_id="O4" value="-14.0" spread="1.99"/>
                    <measurement group_id="O5" value="-9.7" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.9" spread="2.20"/>
                    <measurement group_id="O2" value="-23.6" spread="2.16"/>
                    <measurement group_id="O3" value="-23.9" spread="2.18"/>
                    <measurement group_id="O4" value="-20.8" spread="2.18"/>
                    <measurement group_id="O5" value="-16.2" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.9" spread="2.22"/>
                    <measurement group_id="O2" value="-28.7" spread="2.17"/>
                    <measurement group_id="O3" value="-27.6" spread="2.19"/>
                    <measurement group_id="O4" value="-23.1" spread="2.22"/>
                    <measurement group_id="O5" value="-18.5" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.0" spread="2.08"/>
                    <measurement group_id="O2" value="-32.1" spread="2.03"/>
                    <measurement group_id="O3" value="-31.7" spread="2.05"/>
                    <measurement group_id="O4" value="-30.8" spread="2.08"/>
                    <measurement group_id="O5" value="-20.2" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.7" spread="2.19"/>
                    <measurement group_id="O2" value="-36.8" spread="2.13"/>
                    <measurement group_id="O3" value="-31.0" spread="2.15"/>
                    <measurement group_id="O4" value="-33.0" spread="2.19"/>
                    <measurement group_id="O5" value="-24.3" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.5" spread="2.15"/>
                    <measurement group_id="O2" value="-38.8" spread="2.08"/>
                    <measurement group_id="O3" value="-37.5" spread="2.11"/>
                    <measurement group_id="O4" value="-36.3" spread="2.14"/>
                    <measurement group_id="O5" value="-23.5" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale</title>
        <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale</title>
          <description>100 mm Visual analog scale with descriptors (verbal) : &quot;very good&quot; (0) to &quot;very poor&quot; (100)</description>
          <population>Full Analysis Set</population>
          <units>scores on a visual analog scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.0" spread="17.38"/>
                    <measurement group_id="O2" value="-44.3" spread="19.73"/>
                    <measurement group_id="O3" value="-45.3" spread="19.84"/>
                    <measurement group_id="O4" value="-42.7" spread="19.18"/>
                    <measurement group_id="O5" value="-42.0" spread="20.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-40.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>17.38</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-44.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.73</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-45.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.84</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-42.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.18</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-42.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>20.41</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Global Assessment of Disease Activity</title>
        <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20 and week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Global Assessment of Disease Activity</title>
          <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
          <units>scores on a visual analog scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="1.85"/>
                    <measurement group_id="O2" value="-7.5" spread="1.84"/>
                    <measurement group_id="O3" value="-6.8" spread="1.87"/>
                    <measurement group_id="O4" value="-6.4" spread="1.84"/>
                    <measurement group_id="O5" value="-2.8" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="2.17"/>
                    <measurement group_id="O2" value="-11.9" spread="2.14"/>
                    <measurement group_id="O3" value="-9.5" spread="2.15"/>
                    <measurement group_id="O4" value="-8.8" spread="2.14"/>
                    <measurement group_id="O5" value="-5.9" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.4" spread="2.30"/>
                    <measurement group_id="O2" value="-15.5" spread="2.25"/>
                    <measurement group_id="O3" value="-14.5" spread="2.28"/>
                    <measurement group_id="O4" value="-13.1" spread="2.28"/>
                    <measurement group_id="O5" value="-10.1" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.1" spread="2.52"/>
                    <measurement group_id="O2" value="-20.3" spread="2.46"/>
                    <measurement group_id="O3" value="-16.1" spread="2.49"/>
                    <measurement group_id="O4" value="-16.4" spread="2.51"/>
                    <measurement group_id="O5" value="-11.2" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.5" spread="2.63"/>
                    <measurement group_id="O2" value="-22.0" spread="2.57"/>
                    <measurement group_id="O3" value="-18.7" spread="2.59"/>
                    <measurement group_id="O4" value="-19.4" spread="2.63"/>
                    <measurement group_id="O5" value="-13.8" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.7" spread="2.64"/>
                    <measurement group_id="O2" value="-27.3" spread="2.57"/>
                    <measurement group_id="O3" value="-22.7" spread="2.60"/>
                    <measurement group_id="O4" value="-21.6" spread="2.64"/>
                    <measurement group_id="O5" value="-15.6" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.0" spread="2.60"/>
                    <measurement group_id="O2" value="-33.3" spread="2.52"/>
                    <measurement group_id="O3" value="-33.4" spread="2.56"/>
                    <measurement group_id="O4" value="-30.4" spread="2.60"/>
                    <measurement group_id="O5" value="-21.7" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0167</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Global Assessment of Disease Activity</title>
        <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Global Assessment of Disease Activity</title>
          <description>100 mm Visual analog scale descriptors (verbal) : &quot;very well&quot; (0) to &quot;very poorly&quot;(100)</description>
          <population>Full Analysis Set</population>
          <units>scores on a visual analog scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.2" spread="22.74"/>
                    <measurement group_id="O2" value="-43.8" spread="24.01"/>
                    <measurement group_id="O3" value="-38.4" spread="27.90"/>
                    <measurement group_id="O4" value="-37.9" spread="24.65"/>
                    <measurement group_id="O5" value="-40.5" spread="28.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-42.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>22.74</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-43.8</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>24.01</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-38.4</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>27.90</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-37.9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>24.65</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-40.5</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>28.13</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Pain Assessment</title>
        <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Patient's Pain Assessment up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Pain Assessment</title>
          <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Patient's Pain Assessment up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>scores on a visual analog scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="1.96"/>
                    <measurement group_id="O2" value="-8.1" spread="1.95"/>
                    <measurement group_id="O3" value="-5.1" spread="1.98"/>
                    <measurement group_id="O4" value="-5.8" spread="1.95"/>
                    <measurement group_id="O5" value="-1.6" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" spread="2.15"/>
                    <measurement group_id="O2" value="-12.8" spread="2.12"/>
                    <measurement group_id="O3" value="-8.9" spread="2.13"/>
                    <measurement group_id="O4" value="-6.4" spread="2.12"/>
                    <measurement group_id="O5" value="-3.9" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.9" spread="2.42"/>
                    <measurement group_id="O2" value="-16.1" spread="2.37"/>
                    <measurement group_id="O3" value="-16.6" spread="2.41"/>
                    <measurement group_id="O4" value="-11.9" spread="2.40"/>
                    <measurement group_id="O5" value="-8.5" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.4" spread="2.54"/>
                    <measurement group_id="O2" value="-20.4" spread="2.48"/>
                    <measurement group_id="O3" value="-15.6" spread="2.50"/>
                    <measurement group_id="O4" value="-14.0" spread="2.53"/>
                    <measurement group_id="O5" value="-11.5" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.8" spread="2.58"/>
                    <measurement group_id="O2" value="-23.2" spread="2.52"/>
                    <measurement group_id="O3" value="-20.6" spread="2.55"/>
                    <measurement group_id="O4" value="-19.3" spread="2.59"/>
                    <measurement group_id="O5" value="-12.8" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.8" spread="2.79"/>
                    <measurement group_id="O2" value="-25.3" spread="2.71"/>
                    <measurement group_id="O3" value="-21.4" spread="2.74"/>
                    <measurement group_id="O4" value="-21.4" spread="2.78"/>
                    <measurement group_id="O5" value="-17.1" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.1" spread="2.69"/>
                    <measurement group_id="O2" value="-31.6" spread="2.60"/>
                    <measurement group_id="O3" value="-32.1" spread="2.64"/>
                    <measurement group_id="O4" value="-28.8" spread="2.68"/>
                    <measurement group_id="O5" value="-21.5" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0055</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0487</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Pain Assessment</title>
        <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Pain Assessment</title>
          <description>100 mm Visual Analog Scale with scale (verbal descriptors) &quot;no pain&quot; (0) to &quot;worst possible pain&quot; (100).</description>
          <population>Full Analysis Set</population>
          <units>scores on a visual analog scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.7" spread="21.59"/>
                    <measurement group_id="O2" value="-42.7" spread="25.67"/>
                    <measurement group_id="O3" value="-38.0" spread="29.26"/>
                    <measurement group_id="O4" value="-37.6" spread="26.63"/>
                    <measurement group_id="O5" value="-41.0" spread="29.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-40.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>21.59</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-42.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>25.67</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-38.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>29.26</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-37.6</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>26.63</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-41.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>29.83</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Assessment Questionnaire- Disability Index</title>
        <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire- Disability Index</title>
          <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
          <units>score for the disability index</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0374" spread="0.03454"/>
                    <measurement group_id="O2" value="-0.0453" spread="0.03436"/>
                    <measurement group_id="O3" value="-0.0552" spread="0.03492"/>
                    <measurement group_id="O4" value="-0.0411" spread="0.03435"/>
                    <measurement group_id="O5" value="-0.0045" spread="0.03439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0025" spread="0.04036"/>
                    <measurement group_id="O2" value="-0.0736" spread="0.03984"/>
                    <measurement group_id="O3" value="-0.0906" spread="0.03999"/>
                    <measurement group_id="O4" value="-0.0409" spread="0.03989"/>
                    <measurement group_id="O5" value="-0.0404" spread="0.03928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1510" spread="0.04709"/>
                    <measurement group_id="O2" value="-0.1279" spread="0.04627"/>
                    <measurement group_id="O3" value="-0.2035" spread="0.04687"/>
                    <measurement group_id="O4" value="-0.1041" spread="0.04669"/>
                    <measurement group_id="O5" value="-0.1265" spread="0.04588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1310" spread="0.04601"/>
                    <measurement group_id="O2" value="-0.2140" spread="0.04507"/>
                    <measurement group_id="O3" value="-0.2090" spread="0.04555"/>
                    <measurement group_id="O4" value="-0.1731" spread="0.04597"/>
                    <measurement group_id="O5" value="-0.1374" spread="0.04503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2061" spread="0.04890"/>
                    <measurement group_id="O2" value="-0.2448" spread="0.04790"/>
                    <measurement group_id="O3" value="-0.2343" spread="0.04843"/>
                    <measurement group_id="O4" value="-0.2102" spread="0.04889"/>
                    <measurement group_id="O5" value="-0.1580" spread="0.04801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3052" spread="0.05256"/>
                    <measurement group_id="O2" value="-0.2868" spread="0.05128"/>
                    <measurement group_id="O3" value="-0.2911" spread="0.05185"/>
                    <measurement group_id="O4" value="-0.1947" spread="0.05244"/>
                    <measurement group_id="O5" value="-0.2271" spread="0.05135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3013" spread="0.05196"/>
                    <measurement group_id="O2" value="-0.3314" spread="0.05054"/>
                    <measurement group_id="O3" value="-0.3337" spread="0.05128"/>
                    <measurement group_id="O4" value="-0.2376" spread="0.05187"/>
                    <measurement group_id="O5" value="-0.1827" spread="0.05102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0987</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0360</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0346</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4442</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire- Disability Index</title>
        <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks.&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire- Disability Index</title>
          <description>eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).&#xD;
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability</description>
          <population>Full Analysis Set</population>
          <units>score for the disability index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4869" spread="0.52093"/>
                    <measurement group_id="O2" value="-0.5430" spread="0.59145"/>
                    <measurement group_id="O3" value="-0.4857" spread="0.56968"/>
                    <measurement group_id="O4" value="-0.4583" spread="0.52285"/>
                    <measurement group_id="O5" value="-0.4700" spread="0.54013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4869</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.52093</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5430</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.59145</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4857</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.56968</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4583</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.52285</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.4700</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.54013</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Phase C - Reactive Protein</title>
        <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Phase C - Reactive Protein</title>
          <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>mg/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.967"/>
                    <measurement group_id="O2" value="-0.75" spread="0.961"/>
                    <measurement group_id="O3" value="-0.50" spread="0.979"/>
                    <measurement group_id="O4" value="2.08" spread="0.961"/>
                    <measurement group_id="O5" value="0.51" spread="0.964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="1.239"/>
                    <measurement group_id="O2" value="-3.41" spread="1.227"/>
                    <measurement group_id="O3" value="-0.82" spread="1.223"/>
                    <measurement group_id="O4" value="0.64" spread="1.222"/>
                    <measurement group_id="O5" value="-0.28" spread="1.206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.96" spread="1.506"/>
                    <measurement group_id="O2" value="-3.21" spread="1.476"/>
                    <measurement group_id="O3" value="-1.54" spread="1.502"/>
                    <measurement group_id="O4" value="1.95" spread="1.495"/>
                    <measurement group_id="O5" value="1.24" spread="1.465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.21" spread="1.121"/>
                    <measurement group_id="O2" value="-3.04" spread="1.097"/>
                    <measurement group_id="O3" value="-2.59" spread="1.104"/>
                    <measurement group_id="O4" value="0.11" spread="1.124"/>
                    <measurement group_id="O5" value="1.49" spread="1.097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.37" spread="1.505"/>
                    <measurement group_id="O2" value="-3.57" spread="1.462"/>
                    <measurement group_id="O3" value="-1.67" spread="1.485"/>
                    <measurement group_id="O4" value="-1.58" spread="1.505"/>
                    <measurement group_id="O5" value="2.25" spread="1.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.72" spread="1.708"/>
                    <measurement group_id="O2" value="-2.76" spread="1.656"/>
                    <measurement group_id="O3" value="-2.57" spread="1.677"/>
                    <measurement group_id="O4" value="-0.61" spread="1.715"/>
                    <measurement group_id="O5" value="4.60" spread="1.672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.56" spread="1.088"/>
                    <measurement group_id="O2" value="-2.33" spread="1.054"/>
                    <measurement group_id="O3" value="-3.23" spread="1.071"/>
                    <measurement group_id="O4" value="-2.06" spread="1.088"/>
                    <measurement group_id="O5" value="0.55" spread="1.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0064</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0516</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0114</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0820</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Phase C - Reactive Protein</title>
        <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.&#xD;
Change from Baseline in C-Reactive Protein.</description>
        <time_frame>Week 52</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Phase C - Reactive Protein</title>
          <description>C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.&#xD;
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.&#xD;
Change from Baseline in C-Reactive Protein.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.43" spread="12.506"/>
                    <measurement group_id="O2" value="-3.68" spread="10.770"/>
                    <measurement group_id="O3" value="-6.05" spread="19.004"/>
                    <measurement group_id="O4" value="-4.61" spread="9.508"/>
                    <measurement group_id="O5" value="-6.75" spread="19.649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-3.43</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>12.506</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-3.68</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>10.770</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-6.05</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.004</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.61</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>9.508</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-6.75</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.649</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erythrocyte Sedimentation Rate</title>
        <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate</title>
          <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>mm/hr</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="69"/>
                <count group_id="O4" value="68"/>
                <count group_id="O5" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="1.39"/>
                    <measurement group_id="O2" value="-3.0" spread="1.40"/>
                    <measurement group_id="O3" value="-3.3" spread="1.41"/>
                    <measurement group_id="O4" value="-1.1" spread="1.41"/>
                    <measurement group_id="O5" value="-2.6" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" spread="1.46"/>
                    <measurement group_id="O2" value="-5.9" spread="1.48"/>
                    <measurement group_id="O3" value="-5.5" spread="1.45"/>
                    <measurement group_id="O4" value="-5.6" spread="1.47"/>
                    <measurement group_id="O5" value="-4.8" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="1.58"/>
                    <measurement group_id="O2" value="-6.5" spread="1.58"/>
                    <measurement group_id="O3" value="-7.1" spread="1.58"/>
                    <measurement group_id="O4" value="-5.5" spread="1.60"/>
                    <measurement group_id="O5" value="-3.6" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.6" spread="1.59"/>
                    <measurement group_id="O2" value="-6.8" spread="1.59"/>
                    <measurement group_id="O3" value="-7.9" spread="1.58"/>
                    <measurement group_id="O4" value="-6.6" spread="1.62"/>
                    <measurement group_id="O5" value="-2.3" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.4" spread="1.93"/>
                    <measurement group_id="O2" value="-8.4" spread="1.92"/>
                    <measurement group_id="O3" value="-8.3" spread="1.91"/>
                    <measurement group_id="O4" value="-6.0" spread="1.96"/>
                    <measurement group_id="O5" value="-3.3" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.6" spread="1.73"/>
                    <measurement group_id="O2" value="-7.2" spread="1.72"/>
                    <measurement group_id="O3" value="-9.2" spread="1.71"/>
                    <measurement group_id="O4" value="-8.5" spread="1.76"/>
                    <measurement group_id="O5" value="-4.4" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="1.86"/>
                    <measurement group_id="O2" value="-6.9" spread="1.85"/>
                    <measurement group_id="O3" value="-8.2" spread="1.84"/>
                    <measurement group_id="O4" value="-8.7" spread="1.89"/>
                    <measurement group_id="O5" value="-2.3" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0351</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0876</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0269</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0185</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Sedimentation Rate</title>
        <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Sedimentation Rate</title>
          <description>An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.</description>
          <population>Full Analysis Set</population>
          <units>mm/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" spread="19.58"/>
                    <measurement group_id="O2" value="-7.2" spread="15.26"/>
                    <measurement group_id="O3" value="-8.9" spread="20.48"/>
                    <measurement group_id="O4" value="-9.7" spread="19.02"/>
                    <measurement group_id="O5" value="-9.2" spread="20.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.58</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>15.26</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-8.9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>20.48</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>19.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>20.47</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Subjects Who Require Adjustment of Background Therapy</title>
        <time_frame>Week 16</time_frame>
        <population>Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Subjects Who Require Adjustment of Background Therapy</title>
          <population>Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set</population>
          <units>proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.0127"/>
                    <measurement group_id="O3" value="0.0130"/>
                    <measurement group_id="O4" value="0.0256"/>
                    <measurement group_id="O5" value="0.0127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Proportion with Adjustment of Background</param_type>
            <param_value>1.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>3.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Proportion with Adjustment of Background</param_type>
            <param_value>1.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>3.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Proportion with Adjustment of Background</param_type>
            <param_value>2.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>6.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Proportion with Adjustment of Background</param_type>
            <param_value>1.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>3.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate</title>
        <description>The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).&#xD;
DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of DAS28-CRP Response Rates up to Week 24 Full Analysis Set.&#xD;
DAS28-CRP Response Rates up to Week 52-Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate</title>
          <description>The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).&#xD;
DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health</description>
          <population>Cochran-Mantel-Haenszel Analysis of DAS28-CRP Response Rates up to Week 24 Full Analysis Set.&#xD;
DAS28-CRP Response Rates up to Week 52-Full Analysis Set</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="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.54"/>
                    <measurement group_id="O2" value="12.66"/>
                    <measurement group_id="O3" value="10.39"/>
                    <measurement group_id="O4" value="5.13"/>
                    <measurement group_id="O5" value="6.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.51"/>
                    <measurement group_id="O2" value="17.72"/>
                    <measurement group_id="O3" value="15.58"/>
                    <measurement group_id="O4" value="15.38"/>
                    <measurement group_id="O5" value="13.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.90"/>
                    <measurement group_id="O2" value="29.11"/>
                    <measurement group_id="O3" value="29.87"/>
                    <measurement group_id="O4" value="23.08"/>
                    <measurement group_id="O5" value="18.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.46"/>
                    <measurement group_id="O2" value="40.51"/>
                    <measurement group_id="O3" value="31.17"/>
                    <measurement group_id="O4" value="29.49"/>
                    <measurement group_id="O5" value="18.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.72"/>
                    <measurement group_id="O2" value="48.10"/>
                    <measurement group_id="O3" value="36.36"/>
                    <measurement group_id="O4" value="35.90"/>
                    <measurement group_id="O5" value="13.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.26"/>
                    <measurement group_id="O2" value="60.76"/>
                    <measurement group_id="O3" value="37.66"/>
                    <measurement group_id="O4" value="43.59"/>
                    <measurement group_id="O5" value="21.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.97"/>
                    <measurement group_id="O2" value="64.56"/>
                    <measurement group_id="O3" value="58.44"/>
                    <measurement group_id="O4" value="53.85"/>
                    <measurement group_id="O5" value="30.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="59"/>
                    <count group_id="O4" value="76"/>
                    <count group_id="O5" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.07"/>
                    <measurement group_id="O2" value="81.25"/>
                    <measurement group_id="O3" value="76.27"/>
                    <measurement group_id="O4" value="71.05"/>
                    <measurement group_id="O5" value="65.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>85.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.54</ci_lower_limit>
            <ci_upper_limit>93.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>81.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>71.69</ci_lower_limit>
            <ci_upper_limit>90.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>76.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>65.42</ci_lower_limit>
            <ci_upper_limit>87.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>71.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.86</ci_lower_limit>
            <ci_upper_limit>81.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>65.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>54.56</ci_lower_limit>
            <ci_upper_limit>76.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimal Disease Activity</title>
        <description>A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:&#xD;
tender joint count ≤1;&#xD;
swollen joint count ≤1;&#xD;
PASI score ≤1 or BSA ≤3%;&#xD;
patient Arthritis Pain (VAS)&#xD;
≤15 mm;&#xD;
patient's global arthritis assessment (VAS) ≤20 mm;&#xD;
HAQ-DI score ≤0.5;&#xD;
tender entheseal points (using LEI) ≤1.</description>
        <time_frame>week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52</time_frame>
        <population>Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set.&#xD;
MDA Response Rates up to Week 52- Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Minimal Disease Activity</title>
          <description>A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:&#xD;
tender joint count ≤1;&#xD;
swollen joint count ≤1;&#xD;
PASI score ≤1 or BSA ≤3%;&#xD;
patient Arthritis Pain (VAS)&#xD;
≤15 mm;&#xD;
patient's global arthritis assessment (VAS) ≤20 mm;&#xD;
HAQ-DI score ≤0.5;&#xD;
tender entheseal points (using LEI) ≤1.</description>
          <population>Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set.&#xD;
MDA Response Rates up to Week 52- Full Analysis Set</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="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.27"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85"/>
                    <measurement group_id="O2" value="1.27"/>
                    <measurement group_id="O3" value="1.30"/>
                    <measurement group_id="O4" value="2.56"/>
                    <measurement group_id="O5" value="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85"/>
                    <measurement group_id="O2" value="2.53"/>
                    <measurement group_id="O3" value="2.60"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.82"/>
                    <measurement group_id="O2" value="8.86"/>
                    <measurement group_id="O3" value="7.79"/>
                    <measurement group_id="O4" value="8.97"/>
                    <measurement group_id="O5" value="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.82"/>
                    <measurement group_id="O2" value="6.33"/>
                    <measurement group_id="O3" value="7.79"/>
                    <measurement group_id="O4" value="8.97"/>
                    <measurement group_id="O5" value="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.95"/>
                    <measurement group_id="O2" value="15.19"/>
                    <measurement group_id="O3" value="9.09"/>
                    <measurement group_id="O4" value="8.97"/>
                    <measurement group_id="O5" value="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.33"/>
                    <measurement group_id="O2" value="34.18"/>
                    <measurement group_id="O3" value="28.57"/>
                    <measurement group_id="O4" value="19.23"/>
                    <measurement group_id="O5" value="6.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.92"/>
                    <measurement group_id="O2" value="64.41"/>
                    <measurement group_id="O3" value="45.00"/>
                    <measurement group_id="O4" value="47.06"/>
                    <measurement group_id="O5" value="42.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>56.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.88</ci_lower_limit>
            <ci_upper_limit>68.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>64.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>52.19</ci_lower_limit>
            <ci_upper_limit>76.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>45.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.41</ci_lower_limit>
            <ci_upper_limit>57.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>47.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.20</ci_lower_limit>
            <ci_upper_limit>58.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% response rate</param_type>
            <param_value>42.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.94</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.38</ci_lower_limit>
            <ci_upper_limit>53.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Dactylitis Index (LDI)</title>
        <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
        <time_frame>week 4, week 12, and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LDI up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Dactylitis Index (LDI)</title>
          <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LDI up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="48"/>
                <count group_id="O5" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.385" spread="9.8336"/>
                    <measurement group_id="O2" value="-17.918" spread="9.5818"/>
                    <measurement group_id="O3" value="-19.150" spread="10.4630"/>
                    <measurement group_id="O4" value="-5.385" spread="10.2843"/>
                    <measurement group_id="O5" value="19.891" spread="9.6640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.041" spread="7.8359"/>
                    <measurement group_id="O2" value="-23.163" spread="7.5635"/>
                    <measurement group_id="O3" value="-23.948" spread="8.3579"/>
                    <measurement group_id="O4" value="-9.982" spread="8.2513"/>
                    <measurement group_id="O5" value="-2.990" spread="7.7362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.987" spread="3.5112"/>
                    <measurement group_id="O2" value="-25.123" spread="3.2307"/>
                    <measurement group_id="O3" value="-27.572" spread="3.5088"/>
                    <measurement group_id="O4" value="-19.873" spread="3.4520"/>
                    <measurement group_id="O5" value="-24.706" spread="3.2252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7081</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9244</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5365</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2925</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Dactylitis Index (LDI)</title>
        <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Dactylitis Index (LDI)</title>
          <description>tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)&#xD;
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score&#xD;
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45&#xD;
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.&#xD;
Lower Leeds Dactylitis Index score represent better outcome.</description>
          <population>Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.453" spread="31.9358"/>
                    <measurement group_id="O2" value="-18.883" spread="57.1147"/>
                    <measurement group_id="O3" value="-27.084" spread="76.2272"/>
                    <measurement group_id="O4" value="-26.173" spread="87.5367"/>
                    <measurement group_id="O5" value="-50.399" spread="141.6770"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-14.453</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>31.9358</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-18.883</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>57.1147</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-27.084</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>76.2272</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-26.173</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>87.5367</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-50.399</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>141.6770</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
        <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
        <time_frame>week 4, week 12 and week 24</time_frame>
        <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LEI up to Week 24 - (No Imputation) Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
          <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
          <population>Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LEI up to Week 24 - (No Imputation) Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.15"/>
                    <measurement group_id="O2" value="-0.4" spread="0.14"/>
                    <measurement group_id="O3" value="-0.5" spread="0.14"/>
                    <measurement group_id="O4" value="-0.4" spread="0.14"/>
                    <measurement group_id="O5" value="-0.4" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.15"/>
                    <measurement group_id="O2" value="-0.7" spread="0.14"/>
                    <measurement group_id="O3" value="-0.9" spread="0.15"/>
                    <measurement group_id="O4" value="-0.8" spread="0.15"/>
                    <measurement group_id="O5" value="-0.7" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.16"/>
                    <measurement group_id="O2" value="-0.9" spread="0.15"/>
                    <measurement group_id="O3" value="-1.2" spread="0.15"/>
                    <measurement group_id="O4" value="-1.1" spread="0.15"/>
                    <measurement group_id="O5" value="-0.8" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0203</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5194</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0599</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1220</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
        <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
        <time_frame>Week 52</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>SUNPG1623 I</title>
            <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SUNPG1623 II</title>
            <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O3">
            <title>SUNPG1623 Dose III</title>
            <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
          </group>
          <group group_id="O4">
            <title>SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
            <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
          <group group_id="O5">
            <title>Placebo Moved to SUNPG1623 II After Week 24</title>
            <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leeds Enthesitis Index (LEI)</title>
          <description>The LEI examines tenderness at 6 sites:&#xD;
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.&#xD;
Lower the score better is the outcome</description>
          <population>Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="78"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="1.86"/>
                    <measurement group_id="O2" value="-1.0" spread="1.56"/>
                    <measurement group_id="O3" value="-1.7" spread="2.08"/>
                    <measurement group_id="O4" value="-1.2" spread="1.75"/>
                    <measurement group_id="O5" value="-1.2" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.56</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.75</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.82</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>72 week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1: SUNPG1623 I</title>
          <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Part 1 : SUNPG1623 II</title>
          <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Part 1 : SUNPG1623 Dose III</title>
          <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="E4">
          <title>Part 1 : SUNPG1623 Dose IV</title>
          <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="E5">
          <title>Part 1 : Placebo</title>
          <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="E6">
          <title>Part 2: SUNPG1623 I</title>
          <description>Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks</description>
        </group>
        <group group_id="E7">
          <title>Part 2 : SUNPG1623 II</title>
          <description>Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="E8">
          <title>Part 2 : SUNPG1623 Dose III</title>
          <description>Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks</description>
        </group>
        <group group_id="E9">
          <title>Part 2: Week 24 - 48: SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24</title>
          <description>Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="E10">
          <title>Part 2: Week 24 - 48: Placebo Moved to SUNPG1623 II After Week 24</title>
          <description>Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48</description>
        </group>
        <group group_id="E11">
          <title>Part 3: SUNPG1623 I</title>
          <description>Wash-out period</description>
        </group>
        <group group_id="E12">
          <title>Part 3 : SUNPG1623 II</title>
          <description>Wash-out period</description>
        </group>
        <group group_id="E13">
          <title>Part 3 : SUNPG1623 Dose III</title>
          <description>Wash-out period</description>
        </group>
        <group group_id="E14">
          <title>Part 3 :Wash-out Period (SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24)</title>
          <description>Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Part 2 : Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48&#xD;
Part 3 : wash-out period</description>
        </group>
        <group group_id="E15">
          <title>Part 3 : Wash-out Period (Placebo Moved to SUNPG1623 II After Week 24)</title>
          <description>Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks&#xD;
Part 2 : Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48&#xD;
Part 3 : wash-out period</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst ruptured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="18" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="8" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="79"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head-Clinical Development</name_or_title>
      <organization>Sun Pharma Advanced Research Company Limited</organization>
      <phone>912266455645</phone>
      <email>clinical.trials@sparcmail.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/NCT02980692
org study id: CLR_16_23
nct id: NCT02980692
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to
      demonstrate the safety and efficacy of SUNPG1623
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
time frame: week 24
description: The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
measure: Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
time frame: week 52
description: The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
measure: Proportion of Subjects Achieving American College of Rheumatology50 Response Rate
time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
description: The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
measure: Proportion of Subjects Achieving American College of Rheumatology70 Response Rate
time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52
description: The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.
For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
measure: Change From Baseline in Tender Joint Counts
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
measure: Change From Baseline in Tender Joint Counts
time frame: Week 52
description: Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
measure: Change From Baseline in Swollen Joint Counts
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
measure: Change From Baseline in Swollen Joint Counts
time frame: Week 52
description: Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
measure: Physician Global Assessment of Disease Activity Visual Analog Scale
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: 100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
measure: Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale
time frame: Week 52
description: 100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
measure: Patient's Global Assessment of Disease Activity
time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24
description: 100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity
time frame: Week 52
description: 100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
measure: Patient's Pain Assessment
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: 100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
measure: Change From Baseline in Patient's Pain Assessment
time frame: Week 52
description: 100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
measure: Health Assessment Questionnaire- Disability Index
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index
time frame: Week 52
description: eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).
The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
measure: Acute Phase C - Reactive Protein
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation
measure: Acute Phase C - Reactive Protein
time frame: Week 52
description: C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.
CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.
Change from Baseline in C-Reactive Protein.
measure: Erythrocyte Sedimentation Rate
time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
description: An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
measure: Change From Baseline in Erythrocyte Sedimentation Rate
time frame: Week 52
description: An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
measure: The Proportion of Subjects Who Require Adjustment of Background Therapy
time frame: Week 16
measure: Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate
time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52
description: The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).
DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health
measure: Minimal Disease Activity
time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
description: A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:
tender joint count ≤1;
swollen joint count ≤1;
PASI score ≤1 or BSA ≤3%;
patient Arthritis Pain (VAS)
≤15 mm;
patient's global arthritis assessment (VAS) ≤20 mm;
HAQ-DI score ≤0.5;
tender entheseal points (using LEI) ≤1.
measure: Change From Baseline in Leeds Dactylitis Index (LDI)
time frame: week 4, week 12, and week 24
description: tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.
Lower Leeds Dactylitis Index score represent better outcome.
measure: Change From Baseline in Leeds Dactylitis Index (LDI)
time frame: Week 52
description: tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)
Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score
Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45
The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.
Lower Leeds Dactylitis Index score represent better outcome.
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
time frame: week 4, week 12 and week 24
description: The LEI examines tenderness at 6 sites:
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.
Lower the score better is the outcome
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
time frame: Week 52
description: The LEI examines tenderness at 6 sites:
2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.
Lower the score better is the outcome
arm group label: SUNPG1623 dose I
arm group type: Experimental
description: low range dose
arm group label: SUNPG1623 dose II
arm group type: Experimental
description: mid range dose
arm group label: SUNPG1623 dose III
arm group type: Experimental
description: mid range dose
arm group label: SUNPG1623 dose IV
arm group type: Experimental
description: mid range dose to high dose
arm group label: Placebo
arm group type: Placebo Comparator
description: mid range dose to high dose
intervention type: Drug
intervention name: SUNPG1623 I
description: injection
arm group label: SUNPG1623 dose I
intervention type: Drug
intervention name: SUNPG1623 II
description: injection
arm group label: SUNPG1623 dose II
intervention type: Drug
intervention name: SUNPG1623 III
description: injection
arm group label: SUNPG1623 dose III
intervention type: Drug
intervention name: SUNPG1623 IV
description: injection
arm group label: SUNPG1623 dose IV
intervention type: Drug
intervention name: PLACEBO
description: injection
arm group label: Placebo
arm group label: SUNPG1623 dose II
arm group label: SUNPG1623 dose III
arm group label: SUNPG1623 dose IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 