<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/NCT03245008</url>
  </required_header>
  <id_info>
    <org_study_id>MT-5547-J01</org_study_id>
    <nct_id>NCT03245008</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain</brief_title>
  <official_title>A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to&#xD;
      placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients&#xD;
      with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate&#xD;
      the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The blind will be maintained, including for the study sponsor, until the key code is opened&#xD;
      after the data have been fixed for all subjects in Week 24. In addition, in order to&#xD;
      eliminate any bias that could affect the study assessments, to the extent possible, the blind&#xD;
      will be maintained with respect to the study site and the subject even after the opening of&#xD;
      the study sponsor key code.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">March 9, 2021</completion_date>
  <primary_completion_date type="Actual">December 14, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC Pain Score (Change From Baseline at Week 16)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC Physical Function Score (Change From Baseline at Week 16)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC Total Score (Change From Baseline at Each Assessment Time Point)</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events and Adverse Drug Reactions</measure>
    <time_frame>Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Joint Replacement Procedure is Scheduled</measure>
    <time_frame>Baseline to Week 68</time_frame>
    <description>All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">626</enrollment>
  <condition>Osteoarthritis, Knee / Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>MT-5547 dosing regimen 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MT-5547 dosing regimen 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MT-5547-matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-5547</intervention_name>
    <description>Solution for injection in pre-filled syringe</description>
    <arm_group_label>MT-5547 dosing regimen 1</arm_group_label>
    <arm_group_label>MT-5547 dosing regimen 2</arm_group_label>
    <other_name>Fasinumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-5547-matching placebo</intervention_name>
    <description>Solution for injection in pre-filled syringe</description>
    <arm_group_label>MT-5547 dosing regimen 2</arm_group_label>
    <arm_group_label>MT-5547-matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Additional screening criteria check may apply for qualification:&#xD;
&#xD;
          -  Male and female Japanese patients, 40 years to 85 years at the time written informed&#xD;
             consent is obtained.&#xD;
&#xD;
          -  Patients who have been diagnosed with osteoarthritis (OA) of the knee or hip based on&#xD;
             the American College of Rheumatology (ACR) criteria.&#xD;
&#xD;
          -  Patients with an evaluated joint (knee or hip) with a K-L (Kellgren-Lawrence) score of&#xD;
             ≥2 based on the X-ray test performed.&#xD;
&#xD;
          -  Moderate to severe pain in the evaluated joint, defined as a WOMAC pain score of ≥4&#xD;
             (mean of the 5 items), on the WOMAC assessments.&#xD;
&#xD;
          -  Patients who satisfy both 1) and 2) below.&#xD;
&#xD;
               1. Inadequate OA pain relief from at least 1 oral NSAID.&#xD;
&#xD;
               2. Intolerance to or inadequate OA pain relief from at least 1 opioid (including&#xD;
                  combination drugs), or unwillingness to take opioid therapy.&#xD;
&#xD;
          -  Patients who agree to not change their current lifestyle (daily living activities and&#xD;
             exercise) throughout the study.&#xD;
&#xD;
          -  Patients who are able to complete post-operative follow-up for any joint replacement&#xD;
             surgery that is performed during the study.&#xD;
&#xD;
          -  Body mass index at screening ≤39.&#xD;
&#xD;
          -  Patient who are able to understand and answer endpoint questions used in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Additional screening criteria check may apply for qualification:&#xD;
&#xD;
          -  Presence of symptoms of carpal tunnel syndrome within 6 months before screening.&#xD;
&#xD;
          -  Patients who cannot undergo MRI.&#xD;
&#xD;
          -  Trauma to the index joint within 3 months prior to screening.&#xD;
&#xD;
          -  Presence or history of inflammatory joint diseases other than OA, Paget's disease of&#xD;
             the spine, pelvis or femur, multiple sclerosis, fibromyalgia, vertebral tumors or&#xD;
             infections, or renal osteodystrophy.&#xD;
&#xD;
          -  Presence or history, confirmed by imaging, of arthropathy, neuropathic joint&#xD;
             arthropathy, hip dislocation, knee dislocation, extensive subchondral cyst, marked&#xD;
             bone destruction or bone loss, or pathologic fractures.&#xD;
&#xD;
          -  Autonomic neuropathy diagnosed in the assessment of autonomic nerve symptoms performed&#xD;
             at screening, or baseline.&#xD;
&#xD;
          -  Presence or history of orthostatic hypotension at the orthostatic hypotension&#xD;
             assessments performed at screening, prerandomization, or baseline.&#xD;
&#xD;
          -  Presence or history of autonomic neuropathy, diabetic neuropathy, or other peripheral&#xD;
             neuropathy such as reflex sympathetic dystrophy at screening.&#xD;
&#xD;
          -  Presence or history of chronic familial dysautonomia.&#xD;
&#xD;
          -  Intolerance to naproxen.&#xD;
&#xD;
          -  Systemic (excluding topical, intranasal, ophthalmic, and inhaled formulations)&#xD;
             corticosteroids within 4 weeks prior to screening.&#xD;
&#xD;
          -  Intra-articular corticosteroids in the evaluated joint within 12 weeks prior to&#xD;
             screening, or in any other joint within 4 weeks prior to screening.&#xD;
&#xD;
          -  Received an intra-articular injection of hyaluronic acid in any joint within the&#xD;
             period specified for each medicine prior to screening.&#xD;
&#xD;
          -  Resting heart rate of &lt;50 bpm or &gt;100 bpm at screening, or baseline.&#xD;
&#xD;
          -  Presence or history of 2nd or 3rd degree heart block, 1st degree heart block with&#xD;
             abnormal QRS, or bifascicular block by ECG assessment at screening.&#xD;
&#xD;
          -  Non-compliance with the Numerical rating scale (NRS) recording (average pain on&#xD;
             walking in the evaluated joint over 1 day) during the pre-treatment observation&#xD;
             period.&#xD;
&#xD;
          -  Women who are pregnant, breast-feeding, or may be pregnant.&#xD;
&#xD;
          -  Use of an anti-Nerve growth factor (anti-NGF) antibody in the past, or apparent&#xD;
             hypersensitivity or intolerance to anti-NGF antibodies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>General Manager</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Aomori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Ehime</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Mie</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Shiga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>March 8, 2023</results_first_submitted>
  <results_first_submitted_qc>April 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2023</results_first_posted>
  <last_update_submitted>April 23, 2023</last_update_submitted>
  <last_update_submitted_qc>April 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasinumab</mesh_term>
  </intervention_browse>
  <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>July 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03245008/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03245008/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pooled Placebo</title>
          <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="P2">
          <title>Pooled MT-5547 1 mg q4w</title>
          <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="P3">
          <title>After the Amendment MT-5547 1 mg q8w</title>
          <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="P4">
          <title>MT-5547 3 mg q4w</title>
          <description>This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="P5">
          <title>MT-5547 6 mg q8w</title>
          <description>This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="203"/>
                <participants group_id="P3" count="162"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="159"/>
                <participants group_id="P3" count="132"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <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="4"/>
                <participants group_id="P2" count="1"/>
                <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>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <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="20"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuation of 3 mg q4w and 6 mg q8w doses</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="27"/>
                <participants group_id="P5" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to meet randomization criteria</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="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The pooled placebo group (N=204) and the pooled MT-5547 1 mg q4w group (N=203) showed the total number of participants randomized to each group before and after the protocol amendment.&#xD;
The number of participants who were randomized to the placebo group (N=165) and the MT-5547 1 mg q4w group (N=165) after the protocol amendment were not shown in the table below because they are included in the respective pooled groups. A total of 626 participants were enrolled into this study.</population>
      <group_list>
        <group group_id="B1">
          <title>Pooled Placebo</title>
          <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="B2">
          <title>Pooled MT-5547 1 mg q4w</title>
          <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="B3">
          <title>After the Amendment MT-5547 1 mg q8w</title>
          <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="B4">
          <title>MT-5547 3 mg q4w</title>
          <description>This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="B5">
          <title>MT-5547 6 mg q8w</title>
          <description>This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 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="204"/>
            <count group_id="B2" value="203"/>
            <count group_id="B3" value="162"/>
            <count group_id="B4" value="28"/>
            <count group_id="B5" value="29"/>
            <count group_id="B6" value="626"/>
          </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="67.1" spread="9.4"/>
                    <measurement group_id="B2" value="66.1" spread="9.7"/>
                    <measurement group_id="B3" value="66.6" spread="9.4"/>
                    <measurement group_id="B4" value="68.6" spread="7.6"/>
                    <measurement group_id="B5" value="65.2" spread="7.4"/>
                    <measurement group_id="B6" value="66.6" spread="9.3"/>
                  </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="163"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="126"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="494"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/㎡</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.6" spread="4.3"/>
                    <measurement group_id="B2" value="27.0" spread="4.4"/>
                    <measurement group_id="B3" value="26.8" spread="4.2"/>
                    <measurement group_id="B4" value="24.8" spread="3.4"/>
                    <measurement group_id="B5" value="27.3" spread="4.5"/>
                    <measurement group_id="B6" value="26.8" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Index Joint</title>
          <description>The index joint was the joint (knee or hip) that was judged to have a K-L score of ≥2 in the X-ray (centralized assessment) and the joint with the highest WOMAC pain subscale score (mean of 5 items).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Knee</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="150"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hip</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>K-L Score</title>
          <description>Kellgren-Lawrence category. Osteoarthritis staging category based on simple X-ray; a 5-level scale from 0 to 4. Higher scores indicated worse.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <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>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="82"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score</title>
          <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.93" spread="1.33"/>
                    <measurement group_id="B2" value="6.01" spread="1.31"/>
                    <measurement group_id="B3" value="6.02" spread="1.39"/>
                    <measurement group_id="B4" value="6.32" spread="1.51"/>
                    <measurement group_id="B5" value="6.34" spread="1.29"/>
                    <measurement group_id="B6" value="6.02" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>WOMAC Pain Score (Change From Baseline at Week 16)</title>
        <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Pain Score (Change From Baseline at Week 16)</title>
          <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.74" spread="0.17"/>
                    <measurement group_id="O2" value="-2.96" spread="0.17"/>
                    <measurement group_id="O3" value="-1.78" spread="0.18"/>
                    <measurement group_id="O4" value="-2.12" spread="0.18"/>
                    <measurement group_id="O5" value="-2.79" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Adjusted P-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.57</ci_lower_limit>
            <ci_upper_limit>-0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.103</p_value>
            <p_value_desc>Adjusted P-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Physical Function Score (Change From Baseline at Week 16)</title>
        <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Physical Function Score (Change From Baseline at Week 16)</title>
          <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.38" spread="0.16"/>
                    <measurement group_id="O2" value="-2.64" spread="0.16"/>
                    <measurement group_id="O3" value="-1.44" spread="0.17"/>
                    <measurement group_id="O4" value="-1.88" spread="0.17"/>
                    <measurement group_id="O5" value="-2.53" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Adjusted P-value</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>-0.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)</title>
        <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)</title>
          <description>The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </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="203"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.63" spread="0.14"/>
                    <measurement group_id="O2" value="-1.52" spread="0.14"/>
                    <measurement group_id="O3" value="-0.58" spread="0.14"/>
                    <measurement group_id="O4" value="-1.22" spread="0.15"/>
                    <measurement group_id="O5" value="-1.40" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.80" spread="0.15"/>
                    <measurement group_id="O2" value="-1.80" spread="0.15"/>
                    <measurement group_id="O3" value="-0.78" spread="0.15"/>
                    <measurement group_id="O4" value="-1.55" spread="0.15"/>
                    <measurement group_id="O5" value="-1.65" spread="0.15"/>
                  </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="201"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.03" spread="0.15"/>
                    <measurement group_id="O2" value="-2.10" spread="0.16"/>
                    <measurement group_id="O3" value="-0.98" spread="0.16"/>
                    <measurement group_id="O4" value="-1.68" spread="0.16"/>
                    <measurement group_id="O5" value="-1.90" spread="0.16"/>
                  </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="199"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="160"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="0.16"/>
                    <measurement group_id="O2" value="-2.65" spread="0.16"/>
                    <measurement group_id="O3" value="-1.26" spread="0.17"/>
                    <measurement group_id="O4" value="-1.76" spread="0.17"/>
                    <measurement group_id="O5" value="-2.45" spread="0.17"/>
                  </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="193"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="155"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.62" spread="0.17"/>
                    <measurement group_id="O2" value="-2.77" spread="0.17"/>
                    <measurement group_id="O3" value="-1.61" spread="0.18"/>
                    <measurement group_id="O4" value="-2.27" spread="0.18"/>
                    <measurement group_id="O5" value="-2.56" spread="0.18"/>
                  </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="190"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="152"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.75" spread="0.17"/>
                    <measurement group_id="O2" value="-2.97" spread="0.17"/>
                    <measurement group_id="O3" value="-1.76" spread="0.18"/>
                    <measurement group_id="O4" value="-2.10" spread="0.18"/>
                    <measurement group_id="O5" value="-2.77" spread="0.18"/>
                  </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="189"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="151"/>
                    <count group_id="O4" value="157"/>
                    <count group_id="O5" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.43" spread="0.17"/>
                    <measurement group_id="O2" value="-3.06" spread="0.17"/>
                    <measurement group_id="O3" value="-2.38" spread="0.18"/>
                    <measurement group_id="O4" value="-2.54" spread="0.18"/>
                    <measurement group_id="O5" value="-2.85" spread="0.18"/>
                  </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="186"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.54" spread="0.18"/>
                    <measurement group_id="O2" value="-3.04" spread="0.18"/>
                    <measurement group_id="O3" value="-2.52" spread="0.18"/>
                    <measurement group_id="O4" value="-2.39" spread="0.18"/>
                    <measurement group_id="O5" value="-2.90" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="143"/>
                    <count group_id="O5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.50" spread="0.18"/>
                    <measurement group_id="O2" value="-3.19" spread="0.18"/>
                    <measurement group_id="O3" value="-2.48" spread="0.18"/>
                    <measurement group_id="O4" value="-2.83" spread="0.18"/>
                    <measurement group_id="O5" value="-3.05" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.62" spread="0.18"/>
                    <measurement group_id="O2" value="-3.29" spread="0.18"/>
                    <measurement group_id="O3" value="-2.63" spread="0.18"/>
                    <measurement group_id="O4" value="-2.60" spread="0.18"/>
                    <measurement group_id="O5" value="-3.13" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="135"/>
                    <count group_id="O4" value="136"/>
                    <count group_id="O5" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.66" spread="0.18"/>
                    <measurement group_id="O2" value="-3.16" spread="0.18"/>
                    <measurement group_id="O3" value="-2.72" spread="0.18"/>
                    <measurement group_id="O4" value="-2.84" spread="0.18"/>
                    <measurement group_id="O5" value="-2.99" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.68" spread="0.18"/>
                    <measurement group_id="O2" value="-3.28" spread="0.18"/>
                    <measurement group_id="O3" value="-2.70" spread="0.19"/>
                    <measurement group_id="O4" value="-2.74" spread="0.19"/>
                    <measurement group_id="O5" value="-3.08" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.72" spread="0.18"/>
                    <measurement group_id="O2" value="-3.25" spread="0.18"/>
                    <measurement group_id="O3" value="-2.74" spread="0.18"/>
                    <measurement group_id="O4" value="-3.03" spread="0.18"/>
                    <measurement group_id="O5" value="-3.03" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="132"/>
                    <count group_id="O5" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.75" spread="0.19"/>
                    <measurement group_id="O2" value="-3.17" spread="0.19"/>
                    <measurement group_id="O3" value="-2.75" spread="0.19"/>
                    <measurement group_id="O4" value="-2.77" spread="0.19"/>
                    <measurement group_id="O5" value="-2.99" spread="0.19"/>
                  </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="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="131"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" spread="0.19"/>
                    <measurement group_id="O2" value="-2.80" spread="0.20"/>
                    <measurement group_id="O3" value="-2.43" spread="0.20"/>
                    <measurement group_id="O4" value="-2.42" spread="0.20"/>
                    <measurement group_id="O5" value="-2.56" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.53" spread="0.20"/>
                    <measurement group_id="O2" value="-2.02" spread="0.20"/>
                    <measurement group_id="O3" value="-2.61" spread="0.21"/>
                    <measurement group_id="O4" value="-2.32" spread="0.21"/>
                    <measurement group_id="O5" value="-1.78" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.49" spread="0.20"/>
                    <measurement group_id="O2" value="-2.05" spread="0.21"/>
                    <measurement group_id="O3" value="-2.60" spread="0.20"/>
                    <measurement group_id="O4" value="-2.38" spread="0.20"/>
                    <measurement group_id="O5" value="-1.84" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)</title>
        <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)</title>
          <description>The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </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="203"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="0.14"/>
                    <measurement group_id="O2" value="-1.23" spread="0.14"/>
                    <measurement group_id="O3" value="-0.4" spread="0.14"/>
                    <measurement group_id="O4" value="-0.98" spread="0.14"/>
                    <measurement group_id="O5" value="-1.12" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.14"/>
                    <measurement group_id="O2" value="-1.55" spread="0.14"/>
                    <measurement group_id="O3" value="-0.52" spread="0.14"/>
                    <measurement group_id="O4" value="-1.25" spread="0.14"/>
                    <measurement group_id="O5" value="-1.41" spread="0.14"/>
                  </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="201"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.73" spread="0.15"/>
                    <measurement group_id="O2" value="-1.81" spread="0.15"/>
                    <measurement group_id="O3" value="-0.71" spread="0.15"/>
                    <measurement group_id="O4" value="-1.38" spread="0.15"/>
                    <measurement group_id="O5" value="-1.64" spread="0.15"/>
                  </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="199"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="160"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.97" spread="0.15"/>
                    <measurement group_id="O2" value="-2.34" spread="0.16"/>
                    <measurement group_id="O3" value="-0.94" spread="0.16"/>
                    <measurement group_id="O4" value="-1.48" spread="0.16"/>
                    <measurement group_id="O5" value="-2.17" spread="0.16"/>
                  </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="193"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="155"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="0.16"/>
                    <measurement group_id="O2" value="-2.43" spread="0.16"/>
                    <measurement group_id="O3" value="-1.22" spread="0.17"/>
                    <measurement group_id="O4" value="-1.94" spread="0.17"/>
                    <measurement group_id="O5" value="-2.23" spread="0.17"/>
                  </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="190"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="152"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.40" spread="0.16"/>
                    <measurement group_id="O2" value="-2.66" spread="0.16"/>
                    <measurement group_id="O3" value="-1.40" spread="0.17"/>
                    <measurement group_id="O4" value="-1.84" spread="0.17"/>
                    <measurement group_id="O5" value="-2.49" spread="0.17"/>
                  </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="189"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="151"/>
                    <count group_id="O4" value="157"/>
                    <count group_id="O5" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="0.16"/>
                    <measurement group_id="O2" value="-2.74" spread="0.16"/>
                    <measurement group_id="O3" value="-1.95" spread="0.17"/>
                    <measurement group_id="O4" value="-2.20" spread="0.17"/>
                    <measurement group_id="O5" value="-2.53" spread="0.17"/>
                  </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="186"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="0.17"/>
                    <measurement group_id="O2" value="-2.74" spread="0.17"/>
                    <measurement group_id="O3" value="-2.17" spread="0.18"/>
                    <measurement group_id="O4" value="-2.02" spread="0.18"/>
                    <measurement group_id="O5" value="-2.61" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="143"/>
                    <count group_id="O5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.18" spread="0.17"/>
                    <measurement group_id="O2" value="-2.90" spread="0.17"/>
                    <measurement group_id="O3" value="-2.15" spread="0.17"/>
                    <measurement group_id="O4" value="-2.41" spread="0.17"/>
                    <measurement group_id="O5" value="-2.76" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="0.17"/>
                    <measurement group_id="O2" value="-3.00" spread="0.17"/>
                    <measurement group_id="O3" value="-2.23" spread="0.17"/>
                    <measurement group_id="O4" value="-2.23" spread="0.17"/>
                    <measurement group_id="O5" value="-2.83" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="135"/>
                    <count group_id="O4" value="136"/>
                    <count group_id="O5" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.31" spread="0.17"/>
                    <measurement group_id="O2" value="-2.84" spread="0.17"/>
                    <measurement group_id="O3" value="-2.33" spread="0.17"/>
                    <measurement group_id="O4" value="-2.47" spread="0.17"/>
                    <measurement group_id="O5" value="-2.67" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.29" spread="0.17"/>
                    <measurement group_id="O2" value="-2.91" spread="0.17"/>
                    <measurement group_id="O3" value="-2.29" spread="0.18"/>
                    <measurement group_id="O4" value="-2.46" spread="0.18"/>
                    <measurement group_id="O5" value="-2.71" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" spread="0.17"/>
                    <measurement group_id="O2" value="-2.90" spread="0.17"/>
                    <measurement group_id="O3" value="-2.37" spread="0.17"/>
                    <measurement group_id="O4" value="-2.67" spread="0.18"/>
                    <measurement group_id="O5" value="-2.69" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="132"/>
                    <count group_id="O5" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.38" spread="0.18"/>
                    <measurement group_id="O2" value="-2.83" spread="0.18"/>
                    <measurement group_id="O3" value="-2.35" spread="0.18"/>
                    <measurement group_id="O4" value="-2.46" spread="0.18"/>
                    <measurement group_id="O5" value="-2.61" spread="0.18"/>
                  </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="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="131"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.03" spread="0.18"/>
                    <measurement group_id="O2" value="-2.51" spread="0.19"/>
                    <measurement group_id="O3" value="-2.06" spread="0.19"/>
                    <measurement group_id="O4" value="-2.10" spread="0.19"/>
                    <measurement group_id="O5" value="-2.26" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.18" spread="0.19"/>
                    <measurement group_id="O2" value="-1.75" spread="0.19"/>
                    <measurement group_id="O3" value="-2.22" spread="0.20"/>
                    <measurement group_id="O4" value="-1.98" spread="0.20"/>
                    <measurement group_id="O5" value="-1.52" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.14" spread="0.19"/>
                    <measurement group_id="O2" value="-1.71" spread="0.20"/>
                    <measurement group_id="O3" value="-2.22" spread="0.20"/>
                    <measurement group_id="O4" value="-2.10" spread="0.20"/>
                    <measurement group_id="O5" value="-1.51" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)</title>
        <description>The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)</title>
          <description>The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </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="203"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.15"/>
                    <measurement group_id="O2" value="-1.21" spread="0.15"/>
                    <measurement group_id="O3" value="-0.24" spread="0.15"/>
                    <measurement group_id="O4" value="-0.97" spread="0.15"/>
                    <measurement group_id="O5" value="-1.21" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="0.16"/>
                    <measurement group_id="O2" value="-1.55" spread="0.16"/>
                    <measurement group_id="O3" value="-0.45" spread="0.16"/>
                    <measurement group_id="O4" value="-1.26" spread="0.16"/>
                    <measurement group_id="O5" value="-1.56" spread="0.16"/>
                  </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="201"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="0.16"/>
                    <measurement group_id="O2" value="-1.78" spread="0.16"/>
                    <measurement group_id="O3" value="-0.62" spread="0.17"/>
                    <measurement group_id="O4" value="-1.37" spread="0.17"/>
                    <measurement group_id="O5" value="-1.73" spread="0.17"/>
                  </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="199"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="160"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.72" spread="0.17"/>
                    <measurement group_id="O2" value="-2.29" spread="0.17"/>
                    <measurement group_id="O3" value="-0.75" spread="0.17"/>
                    <measurement group_id="O4" value="-1.47" spread="0.18"/>
                    <measurement group_id="O5" value="-2.24" spread="0.18"/>
                  </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="193"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="155"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.17"/>
                    <measurement group_id="O2" value="-2.36" spread="0.18"/>
                    <measurement group_id="O3" value="-1.01" spread="0.18"/>
                    <measurement group_id="O4" value="-1.94" spread="0.18"/>
                    <measurement group_id="O5" value="-2.30" spread="0.18"/>
                  </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="190"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="152"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.21" spread="0.17"/>
                    <measurement group_id="O2" value="-2.63" spread="0.18"/>
                    <measurement group_id="O3" value="-1.24" spread="0.18"/>
                    <measurement group_id="O4" value="-1.78" spread="0.18"/>
                    <measurement group_id="O5" value="-2.58" spread="0.18"/>
                  </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="189"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="151"/>
                    <count group_id="O4" value="157"/>
                    <count group_id="O5" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.93" spread="0.17"/>
                    <measurement group_id="O2" value="-2.74" spread="0.18"/>
                    <measurement group_id="O3" value="-1.95" spread="0.18"/>
                    <measurement group_id="O4" value="-2.21" spread="0.18"/>
                    <measurement group_id="O5" value="-2.65" spread="0.18"/>
                  </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="186"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="0.17"/>
                    <measurement group_id="O2" value="-2.80" spread="0.18"/>
                    <measurement group_id="O3" value="-2.16" spread="0.18"/>
                    <measurement group_id="O4" value="-1.86" spread="0.18"/>
                    <measurement group_id="O5" value="-2.74" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="143"/>
                    <count group_id="O5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="0.17"/>
                    <measurement group_id="O2" value="-2.96" spread="0.18"/>
                    <measurement group_id="O3" value="-2.01" spread="0.18"/>
                    <measurement group_id="O4" value="-2.31" spread="0.18"/>
                    <measurement group_id="O5" value="-2.89" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" spread="0.18"/>
                    <measurement group_id="O2" value="-2.94" spread="0.18"/>
                    <measurement group_id="O3" value="-2.31" spread="0.19"/>
                    <measurement group_id="O4" value="-2.19" spread="0.19"/>
                    <measurement group_id="O5" value="-2.86" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="135"/>
                    <count group_id="O4" value="136"/>
                    <count group_id="O5" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.16" spread="0.18"/>
                    <measurement group_id="O2" value="-2.91" spread="0.18"/>
                    <measurement group_id="O3" value="-2.23" spread="0.18"/>
                    <measurement group_id="O4" value="-2.53" spread="0.18"/>
                    <measurement group_id="O5" value="-2.87" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.16" spread="0.18"/>
                    <measurement group_id="O2" value="-2.97" spread="0.18"/>
                    <measurement group_id="O3" value="-2.24" spread="0.18"/>
                    <measurement group_id="O4" value="-2.44" spread="0.18"/>
                    <measurement group_id="O5" value="-2.92" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.29" spread="0.18"/>
                    <measurement group_id="O2" value="-3.01" spread="0.18"/>
                    <measurement group_id="O3" value="-2.38" spread="0.18"/>
                    <measurement group_id="O4" value="-2.56" spread="0.18"/>
                    <measurement group_id="O5" value="-2.93" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="132"/>
                    <count group_id="O5" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.27" spread="0.19"/>
                    <measurement group_id="O2" value="-2.87" spread="0.19"/>
                    <measurement group_id="O3" value="-2.34" spread="0.19"/>
                    <measurement group_id="O4" value="-2.34" spread="0.19"/>
                    <measurement group_id="O5" value="-2.81" spread="0.19"/>
                  </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="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="131"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" spread="0.20"/>
                    <measurement group_id="O2" value="-2.51" spread="0.20"/>
                    <measurement group_id="O3" value="-1.93" spread="0.20"/>
                    <measurement group_id="O4" value="-1.98" spread="0.20"/>
                    <measurement group_id="O5" value="-2.44" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.06" spread="0.21"/>
                    <measurement group_id="O2" value="-1.51" spread="0.21"/>
                    <measurement group_id="O3" value="-2.17" spread="0.21"/>
                    <measurement group_id="O4" value="-1.85" spread="0.21"/>
                    <measurement group_id="O5" value="-1.45" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="0.21"/>
                    <measurement group_id="O2" value="-1.49" spread="0.21"/>
                    <measurement group_id="O3" value="-2.23" spread="0.21"/>
                    <measurement group_id="O4" value="-1.90" spread="0.21"/>
                    <measurement group_id="O5" value="-1.44" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WOMAC Total Score (Change From Baseline at Each Assessment Time Point)</title>
        <description>The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>WOMAC Total Score (Change From Baseline at Each Assessment Time Point)</title>
          <description>The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </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="203"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.13"/>
                    <measurement group_id="O2" value="-1.29" spread="0.13"/>
                    <measurement group_id="O3" value="-0.42" spread="0.13"/>
                    <measurement group_id="O4" value="-1.03" spread="0.14"/>
                    <measurement group_id="O5" value="-1.18" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="0.14"/>
                    <measurement group_id="O2" value="-1.60" spread="0.14"/>
                    <measurement group_id="O3" value="-0.56" spread="0.14"/>
                    <measurement group_id="O4" value="-1.31" spread="0.14"/>
                    <measurement group_id="O5" value="-1.47" spread="0.14"/>
                  </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="201"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="0.14"/>
                    <measurement group_id="O2" value="-1.87" spread="0.15"/>
                    <measurement group_id="O3" value="-0.75" spread="0.15"/>
                    <measurement group_id="O4" value="-1.44" spread="0.15"/>
                    <measurement group_id="O5" value="-1.70" spread="0.15"/>
                  </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="199"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="160"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.02" spread="0.15"/>
                    <measurement group_id="O2" value="-2.40" spread="0.15"/>
                    <measurement group_id="O3" value="-0.98" spread="0.15"/>
                    <measurement group_id="O4" value="-1.54" spread="0.16"/>
                    <measurement group_id="O5" value="-2.23" spread="0.15"/>
                  </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="193"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="155"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="0.16"/>
                    <measurement group_id="O2" value="-2.49" spread="0.16"/>
                    <measurement group_id="O3" value="-1.28" spread="0.17"/>
                    <measurement group_id="O4" value="-2.01" spread="0.17"/>
                    <measurement group_id="O5" value="-2.31" spread="0.17"/>
                  </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="190"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="152"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" spread="0.16"/>
                    <measurement group_id="O2" value="-2.72" spread="0.16"/>
                    <measurement group_id="O3" value="-1.45" spread="0.17"/>
                    <measurement group_id="O4" value="-1.89" spread="0.17"/>
                    <measurement group_id="O5" value="-2.56" spread="0.17"/>
                  </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="189"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="151"/>
                    <count group_id="O4" value="157"/>
                    <count group_id="O5" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.10" spread="0.16"/>
                    <measurement group_id="O2" value="-2.81" spread="0.16"/>
                    <measurement group_id="O3" value="-2.03" spread="0.17"/>
                    <measurement group_id="O4" value="-2.27" spread="0.17"/>
                    <measurement group_id="O5" value="-2.60" spread="0.17"/>
                  </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="186"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.28" spread="0.17"/>
                    <measurement group_id="O2" value="-2.81" spread="0.17"/>
                    <measurement group_id="O3" value="-2.24" spread="0.17"/>
                    <measurement group_id="O4" value="-2.08" spread="0.17"/>
                    <measurement group_id="O5" value="-2.68" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="143"/>
                    <count group_id="O5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.23" spread="0.16"/>
                    <measurement group_id="O2" value="-2.97" spread="0.17"/>
                    <measurement group_id="O3" value="-2.20" spread="0.17"/>
                    <measurement group_id="O4" value="-2.49" spread="0.17"/>
                    <measurement group_id="O5" value="-2.83" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.30" spread="0.17"/>
                    <measurement group_id="O2" value="-3.06" spread="0.17"/>
                    <measurement group_id="O3" value="-2.31" spread="0.17"/>
                    <measurement group_id="O4" value="-2.30" spread="0.17"/>
                    <measurement group_id="O5" value="-2.89" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="135"/>
                    <count group_id="O4" value="136"/>
                    <count group_id="O5" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.37" spread="0.17"/>
                    <measurement group_id="O2" value="-2.91" spread="0.17"/>
                    <measurement group_id="O3" value="-2.39" spread="0.17"/>
                    <measurement group_id="O4" value="-2.55" spread="0.17"/>
                    <measurement group_id="O5" value="-2.75" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="0.17"/>
                    <measurement group_id="O2" value="-2.99" spread="0.17"/>
                    <measurement group_id="O3" value="-2.36" spread="0.17"/>
                    <measurement group_id="O4" value="-2.51" spread="0.18"/>
                    <measurement group_id="O5" value="-2.80" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="0.17"/>
                    <measurement group_id="O2" value="-2.98" spread="0.17"/>
                    <measurement group_id="O3" value="-2.44" spread="0.17"/>
                    <measurement group_id="O4" value="-2.73" spread="0.17"/>
                    <measurement group_id="O5" value="-2.78" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="132"/>
                    <count group_id="O5" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.45" spread="0.17"/>
                    <measurement group_id="O2" value="-2.91" spread="0.18"/>
                    <measurement group_id="O3" value="-2.42" spread="0.18"/>
                    <measurement group_id="O4" value="-2.51" spread="0.18"/>
                    <measurement group_id="O5" value="-2.70" spread="0.18"/>
                  </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="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="131"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="0.18"/>
                    <measurement group_id="O2" value="-2.57" spread="0.18"/>
                    <measurement group_id="O3" value="-2.11" spread="0.19"/>
                    <measurement group_id="O4" value="-2.15" spread="0.19"/>
                    <measurement group_id="O5" value="-2.33" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.24" spread="0.19"/>
                    <measurement group_id="O2" value="-1.79" spread="0.19"/>
                    <measurement group_id="O3" value="-2.29" spread="0.20"/>
                    <measurement group_id="O4" value="-2.04" spread="0.20"/>
                    <measurement group_id="O5" value="-1.57" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" spread="0.19"/>
                    <measurement group_id="O2" value="-1.76" spread="0.19"/>
                    <measurement group_id="O3" value="-2.29" spread="0.20"/>
                    <measurement group_id="O4" value="-2.14" spread="0.20"/>
                    <measurement group_id="O5" value="-1.57" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)</title>
        <description>Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Pooled MT-5547 1 mg q4w</title>
            <description>This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>After the Amendment Placebo</title>
            <description>Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.</description>
          </group>
          <group group_id="O4">
            <title>After the Amendment MT-5547 1 mg q8w</title>
            <description>This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>After the Amendment MT-5547 1 mg q4w</title>
            <description>Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment.&#xD;
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.&#xD;
These participants were included in the pooled MT-5547 1mg q4w group.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)</title>
          <description>Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).</description>
          <population>Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="203"/>
                <count group_id="O3" value="165"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="165"/>
              </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="203"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.1"/>
                    <measurement group_id="O2" value="-0.7" spread="0.1"/>
                    <measurement group_id="O3" value="-0.4" spread="0.1"/>
                    <measurement group_id="O4" value="-0.7" spread="0.1"/>
                    <measurement group_id="O5" value="-0.7" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="162"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.1"/>
                    <measurement group_id="O2" value="-0.8" spread="0.1"/>
                    <measurement group_id="O3" value="-0.5" spread="0.1"/>
                    <measurement group_id="O4" value="-0.9" spread="0.1"/>
                    <measurement group_id="O5" value="-0.8" spread="0.1"/>
                  </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="201"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="163"/>
                    <count group_id="O4" value="162"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.1"/>
                    <measurement group_id="O2" value="-1.0" spread="0.1"/>
                    <measurement group_id="O3" value="-0.5" spread="0.1"/>
                    <measurement group_id="O4" value="-0.9" spread="0.1"/>
                    <measurement group_id="O5" value="-1.0" spread="0.1"/>
                  </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="199"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="160"/>
                    <count group_id="O5" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-0.7" spread="0.1"/>
                    <measurement group_id="O4" value="-0.9" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </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="194"/>
                    <count group_id="O2" value="197"/>
                    <count group_id="O3" value="156"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.1"/>
                    <measurement group_id="O2" value="-1.1" spread="0.1"/>
                    <measurement group_id="O3" value="-0.8" spread="0.1"/>
                    <measurement group_id="O4" value="-1.2" spread="0.1"/>
                    <measurement group_id="O5" value="-1.1" spread="0.1"/>
                  </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="190"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="152"/>
                    <count group_id="O4" value="158"/>
                    <count group_id="O5" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-0.9" spread="0.1"/>
                    <measurement group_id="O4" value="-1.1" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </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="189"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="151"/>
                    <count group_id="O4" value="157"/>
                    <count group_id="O5" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-1.1" spread="0.1"/>
                    <measurement group_id="O4" value="-1.1" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </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="186"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.1"/>
                    <measurement group_id="O2" value="-1.1" spread="0.1"/>
                    <measurement group_id="O3" value="-1.2" spread="0.1"/>
                    <measurement group_id="O4" value="-1.1" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="143"/>
                    <count group_id="O5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.1"/>
                    <measurement group_id="O2" value="-1.3" spread="0.1"/>
                    <measurement group_id="O3" value="-1.1" spread="0.1"/>
                    <measurement group_id="O4" value="-1.2" spread="0.1"/>
                    <measurement group_id="O5" value="-1.3" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-1.1" spread="0.1"/>
                    <measurement group_id="O4" value="-1.0" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="135"/>
                    <count group_id="O4" value="136"/>
                    <count group_id="O5" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-1.2" spread="0.1"/>
                    <measurement group_id="O4" value="-1.1" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.1"/>
                    <measurement group_id="O2" value="-1.2" spread="0.1"/>
                    <measurement group_id="O3" value="-1.1" spread="0.1"/>
                    <measurement group_id="O4" value="-1.0" spread="0.1"/>
                    <measurement group_id="O5" value="-1.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.1"/>
                    <measurement group_id="O2" value="-1.1" spread="0.1"/>
                    <measurement group_id="O3" value="-1.2" spread="0.1"/>
                    <measurement group_id="O4" value="-1.2" spread="0.1"/>
                    <measurement group_id="O5" value="-1.1" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="133"/>
                    <count group_id="O4" value="132"/>
                    <count group_id="O5" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.1"/>
                    <measurement group_id="O2" value="-1.1" spread="0.1"/>
                    <measurement group_id="O3" value="-1.1" spread="0.1"/>
                    <measurement group_id="O4" value="-1.1" spread="0.1"/>
                    <measurement group_id="O5" value="-1.1" spread="0.1"/>
                  </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="167"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="131"/>
                    <count group_id="O4" value="133"/>
                    <count group_id="O5" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.1"/>
                    <measurement group_id="O2" value="-0.9" spread="0.1"/>
                    <measurement group_id="O3" value="-0.9" spread="0.1"/>
                    <measurement group_id="O4" value="-0.9" spread="0.1"/>
                    <measurement group_id="O5" value="-0.9" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="127"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.1"/>
                    <measurement group_id="O2" value="-0.5" spread="0.1"/>
                    <measurement group_id="O3" value="-1.0" spread="0.1"/>
                    <measurement group_id="O4" value="-0.8" spread="0.1"/>
                    <measurement group_id="O5" value="-0.5" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.1"/>
                    <measurement group_id="O2" value="-0.5" spread="0.1"/>
                    <measurement group_id="O3" value="-1.0" spread="0.1"/>
                    <measurement group_id="O4" value="-0.8" spread="0.1"/>
                    <measurement group_id="O5" value="-0.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events and Adverse Drug Reactions</title>
        <time_frame>Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)</time_frame>
        <population>The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants&#xD;
participants who did not receive study drug even once&#xD;
participants for whom absolutely no post-randomization safety data are available</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>MT-5547 1 mg q8w</title>
            <description>MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.&#xD;
Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>MT-5547 1mg q4w</title>
            <description>MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O4">
            <title>MT-5547 3 mg q4w</title>
            <description>Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>MT-5547 6 mg q8w</title>
            <description>Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events and Adverse Drug Reactions</title>
          <population>The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants&#xD;
participants who did not receive study drug even once&#xD;
participants for whom absolutely no post-randomization safety data are available</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="162"/>
                <count group_id="O3" value="203"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with at least one AE (Treatment Period)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="136"/>
                    <measurement group_id="O3" value="168"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with at least one adverse drug reaction (treatment period)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with at least one AE (post-treatment period)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="83"/>
                    <measurement group_id="O3" value="117"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with at least one adverse drug reaction (post-treatment period)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Joint Replacement Procedure is Scheduled</title>
        <description>All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.</description>
        <time_frame>Baseline to Week 68</time_frame>
        <population>The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants&#xD;
participants who did not receive study drug even once&#xD;
participants for whom absolutely no post-randomization safety data are available</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>MT-5547 1 mg q8w</title>
            <description>MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.&#xD;
Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O3">
            <title>MT-5547 1mg q4w</title>
            <description>MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O4">
            <title>MT-5547 3 mg q4w</title>
            <description>Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
          <group group_id="O5">
            <title>MT-5547 6 mg q8w</title>
            <description>Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Joint Replacement Procedure is Scheduled</title>
          <description>All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.</description>
          <population>The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants&#xD;
participants who did not receive study drug even once&#xD;
participants for whom absolutely no post-randomization safety data are available</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="162"/>
                <count group_id="O3" value="203"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)</time_frame>
      <desc>The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants&#xD;
participants who did not receive study drug even once&#xD;
participants for whom absolutely no post-randomization safety data are available Reported AEs &amp; deaths are treatment emergent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo, On-treatment Period</title>
          <description>Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E2">
          <title>MT-5547 1 mg q8w, On-treatment Period</title>
          <description>MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.&#xD;
Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E3">
          <title>MT-5547 1mg q4w, On-treatment Period</title>
          <description>MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E4">
          <title>MT-5547 3 mg q4w, On-treatment Period</title>
          <description>Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E5">
          <title>MT-5547 6 mg q8w, On-treatment Period</title>
          <description>Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E6">
          <title>Placebo, Post-treatment Observation Period</title>
          <description>Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.&#xD;
Naproxen oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E7">
          <title>MT-5547 1 mg q8w, Post-treatment Observation Period</title>
          <description>MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.&#xD;
Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E8">
          <title>MMT-5547 1mg q4w, Post-treatment Observation Period</title>
          <description>MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E9">
          <title>MT-5547 3 mg q4w, Post-treatment Observation Period</title>
          <description>Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
        <group group_id="E10">
          <title>MT-5547 6 mg q8w, Post-treatment Observation Period</title>
          <description>Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.&#xD;
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Encephalitis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Heat illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Rapidly progressive osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Thymoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Uterine cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Corticobasal degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Status asthmaticus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="118" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="51" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="37" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="65" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="62" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Rapidly progressive osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="17" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="203"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="203"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="29"/>
              </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>Clinical Trials, Information Desk</name_or_title>
      <organization>Mitsubishi Tanabe Pharma Corporation</organization>
      <phone>Please email</phone>
      <email>cti-inq-ml@ml.mt-pharma.co.jp</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/NCT03245008
org study id: MT-5547-J01
nct id: NCT03245008
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to
      placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients
      with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate
      the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.
The blind will be maintained, including for the study sponsor, until the key code is opened
      after the data have been fixed for all subjects in Week 24. In addition, in order to
      eliminate any bias that could affect the study assessments, to the extent possible, the blind
      will be maintained with respect to the study site and the subject even after the opening of
      the study sponsor key code.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: WOMAC Pain Score (Change From Baseline at Week 16)
time frame: Baseline to Week 16
description: The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.
measure: WOMAC Physical Function Score (Change From Baseline at Week 16)
time frame: Baseline to Week 16
description: The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
measure: WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)
time frame: Baseline to Week 68
description: The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.
measure: WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
time frame: Baseline to Week 68
description: The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
measure: WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
time frame: Baseline to Week 68
description: The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.
measure: WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
time frame: Baseline to Week 68
description: The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.
measure: Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)
time frame: Baseline to Week 68
description: Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).
measure: Number of Participants With Adverse Events and Adverse Drug Reactions
time frame: Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
measure: Number of Participants With a Joint Replacement Procedure is Scheduled
time frame: Baseline to Week 68
description: All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.
arm group label: MT-5547 dosing regimen 1
arm group type: Experimental
description: MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16.
arm group label: MT-5547 dosing regimen 2
arm group type: Experimental
description: MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16.
arm group label: MT-5547-matching placebo
arm group type: Placebo Comparator
description: MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.
intervention type: Drug
intervention name: MT-5547
description: Solution for injection in pre-filled syringe
arm group label: MT-5547 dosing regimen 1
arm group label: MT-5547 dosing regimen 2
other name: Fasinumab
intervention type: Drug
intervention name: MT-5547-matching placebo
description: Solution for injection in pre-filled syringe
arm group label: MT-5547 dosing regimen 2
arm group label: MT-5547-matching placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: General Manager
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Corporation
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country: Japan
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Fasinumab
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 