<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/NCT03290781</url>
  </required_header>
  <id_info>
    <org_study_id>SHP647-303</org_study_id>
    <secondary_id>2017-000573-37</secondary_id>
    <nct_id>NCT03290781</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis</brief_title>
  <acronym>FIGARO UC 303</acronym>
  <official_title>A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy&#xD;
      treatment of remission, based on composite score of patient-reported symptoms and centrally&#xD;
      read endoscopy, in participants with moderate to severe ulcerative colitis (UC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2018</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Remission Based on Composite Score at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Endoscopic Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sustained Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Response Based on Composite Score at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or a sub-score for rectal bleeding &lt;= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood &amp; 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Glucocorticoid-free Clinical Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood &amp; 3=blood alone passes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Glucocorticoid-free Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Total Mayo Score at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Remission defined as a total mayo score of less than or equal to (&lt;=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0</measure>
    <time_frame>At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sustained Endoscopic Remission at Week 52</measure>
    <time_frame>At Week 52</time_frame>
    <description>Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to follow-up (Week 64)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab</measure>
    <time_frame>At Week 12, 24, 36 and 52</time_frame>
    <description>Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Ontamalimab 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ontamalimab 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ontamalimab</intervention_name>
    <description>Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).</description>
    <arm_group_label>Ontamalimab 25 mg</arm_group_label>
    <arm_group_label>Ontamalimab 75 mg</arm_group_label>
    <other_name>PF-00547659</other_name>
    <other_name>SHP647</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive 1 mL of sterile aqueous buffered solution.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants and/or their parent or legally authorized representative must have an&#xD;
             understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          -  Participants must be able to voluntarily provide written, signed, and dated&#xD;
             (personally or via a legally authorized representative) informed consent and/or&#xD;
             assent, as applicable, to participate in the study.&#xD;
&#xD;
          -  Participants must have completed the 12-week induction treatment period (SHP647-301&#xD;
             [NCT03259334] and SHP647-302 [NCT03259308]).&#xD;
&#xD;
          -  Participants must have achieved clinical response in induction study (SHP647-301&#xD;
             [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:&#xD;
&#xD;
             i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302&#xD;
             [NCT03259308]) baseline in the composite score of patient reported symptoms using&#xD;
             daily e-diary and centrally read endoscopy of at least 2 points and at least 30&#xD;
             percent (%), with an accompanying decrease in the sub score for rectal bleeding&#xD;
             greater than or equal to (&gt;=) 1 point or a sub score for rectal bleeding less than or&#xD;
             equal to (&lt;=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334]&#xD;
             and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at&#xD;
             least 30%, with an accompanying decrease in the rectal bleeding sub score of at least&#xD;
             1 point or an absolute rectal bleeding sub score of 0 or 1.&#xD;
&#xD;
        For eligibility assessment, clinical response will be determined based on the centrally&#xD;
        read endoscopy performed during screening and at Week 12 of induction study (SHP647-301&#xD;
        [NCT03259334] and SHP647-302 [NCT03259308]).&#xD;
&#xD;
        - Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided&#xD;
        they have been, and are anticipated to be, on a stable dose for the designated period of&#xD;
        time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who had major protocol deviation(s) (as determined by the sponsor) in&#xD;
             induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).&#xD;
&#xD;
          -  Participants who permanently discontinued investigational product because of an&#xD;
             adverse event (AE), regardless of relatedness to investigational product, in induction&#xD;
             study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).&#xD;
&#xD;
          -  Participants who are likely to require surgery for UC during the study period.&#xD;
&#xD;
          -  Participants are females who became pregnant during induction study (SHP647-301&#xD;
             [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become&#xD;
             pregnant during the study period, or males or females of childbearing potential not&#xD;
             agreeing to continue using appropriate contraception methods (that is [i.e,] highly&#xD;
             effective methods for female and medically appropriate methods for male study&#xD;
             participants) through the conclusion of study participation.&#xD;
&#xD;
          -  Participants who do not agree to postpone donation of any organ or tissue, including&#xD;
             male participants who are planning to bank or donate sperm and female participants who&#xD;
             are planning to harvest or donate eggs, for the duration of the study and through 16&#xD;
             weeks after last dose of investigational product.&#xD;
&#xD;
          -  Participants who, in the opinion of the investigator or the sponsor, will be&#xD;
             uncooperative or unable to comply with study procedures.&#xD;
&#xD;
          -  Participants who have a newly diagnosed malignancy or recurrence of malignancy (other&#xD;
             than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in&#xD;
             situ of the uterine cervix that has been treated with no evidence of recurrence).&#xD;
&#xD;
          -  Participants who have developed any major illness/condition or evidence of an unstable&#xD;
             clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal&#xD;
             (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg,&#xD;
             Felty's syndrome], or local active infection/infectious illness) that, in the&#xD;
             investigator's judgment, will substantially increase the risk to the participant if he&#xD;
             or she participates in the study.&#xD;
&#xD;
          -  Participants with any other severe acute or chronic medical or psychiatric condition&#xD;
             or laboratory or electrocardiogram (ECG) abnormality that may increase the risk&#xD;
             associated with study participation or investigational product administration or may&#xD;
             interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at&#xD;
             screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308])&#xD;
             and who are without a generally accepted course of treatment.&#xD;
&#xD;
          -  Participants who are investigational site staff members or relatives of those site&#xD;
             staff members or participants who are sponsor employees directly involved in the&#xD;
             conduct of the study.&#xD;
&#xD;
          -  Participants who are participating in or plan to participate in other investigational&#xD;
             studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302&#xD;
             [NCT03259308]) during study SHP647-303 [NCT03290781].&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Shire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Digestive Health Mesa - East</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies - Phoenix - Clinedge - PPDS</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atria Clinical Research - Clinedge - PPDS</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindred Medical Institute for Clinical Trials, LLC</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Doctors</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024-1350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OM Research LLC - Lancaster - ClinEdge - PPDS</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System - NAVREF - PPDS</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facey Medical Foundation</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Doctors</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Clinical Research-(Vestavia Hills)</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Empire Liver Foundation</name>
      <address>
        <city>Rialto</city>
        <state>California</state>
        <zip>92377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research, San Pablo</name>
      <address>
        <city>San Pablo</city>
        <state>California</state>
        <zip>94806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peak Gastroenterology Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma and Allergy Associates PC - CRN - PPDS</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renaissance Research Medical Group, INC</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33991</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Network</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Medical Research LLC</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENCORE Borland-Groover Clinical Research - ERN - PPDS</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>SIH Research</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crystal Biomedical Research</name>
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        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hi Tech and Global Research, LLc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Nuren Medical and Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanchez Clinical Research, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Group of Naples</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Pharma Research International Inc</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Omega Research Consultants LLC - Clinedge - PPDS</name>
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        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Accel Research Sites - St. Petersburg - ERN - PPDS</name>
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        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>BRCR Medical Center, Inc</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33322</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute for Research, LLC</name>
      <address>
        <city>Saint Augustine</city>
        <state>Florida</state>
        <zip>32086</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>DBC Research</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Bayside Clinical Research - New Port Richey</name>
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        <city>Tampa</city>
        <state>Florida</state>
        <zip>33604</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Specialists, PC</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Infinite Clinical Trials</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30349</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center For Gastroenterology PC</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Loretto Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60644</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IL Gastroenterology Group</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edward Hines Jr VA Hospital - NAVREF - PPDS</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dupage Medical Group</name>
      <address>
        <city>Oakbrook Terrace</city>
        <state>Illinois</state>
        <zip>60181</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisphere Medical Research Center LLC</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laporte County Institute For Clinical Research</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Hazard</name>
      <address>
        <city>Hazard</city>
        <state>Kentucky</state>
        <zip>41701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CroNOLA, LLC.</name>
      <address>
        <city>Houma</city>
        <state>Louisiana</state>
        <zip>70360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of SWLA, LLC</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Center LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chevy Chase Clinical Research</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Clinical Studies LLC</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical, LLC</name>
      <address>
        <city>Hamtramck</city>
        <state>Michigan</state>
        <zip>48212</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System - PPDS</name>
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        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Center PA</name>
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        <city>Ocean Springs</city>
        <state>Mississippi</state>
        <zip>39564</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Louis Center For Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Advanced Biomedical Research of America</name>
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        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Care</name>
      <address>
        <city>North Las Vegas</city>
        <state>Nevada</state>
        <zip>89086</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>New York Total Medical Care PC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Long Island Clinical Research Associates</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southtowns Gastroenterology, PLLC</name>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina Gastroenterology</name>
      <address>
        <city>Jacksonville</city>
        <state>North Carolina</state>
        <zip>28546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare</name>
      <address>
        <city>Statesville</city>
        <state>North Carolina</state>
        <zip>28625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants For Clinical Research Inc</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants For Clinical Research Inc</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants For Clinical Research Inc</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestige Clinical Research</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Clinical Research Partners LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veteran's Research and Education Foundation - NAVREF - PPDS</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Research Foundation of Pittsburgh - NAVREF - PPDS</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro One</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Gastroenterology-Union City</name>
      <address>
        <city>Union City</city>
        <state>Tennessee</state>
        <zip>38237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Gastroenterology</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates of Texas, P.A.dba DHAT Research Institute</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Clinical Trials</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aztec Medical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BI Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Star Research Institute LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research - ERN - PPDS</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HP Clinical Research</name>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <zip>84010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Health Specialists</name>
      <address>
        <city>Galax</city>
        <state>Virginia</state>
        <zip>24333</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester Gastroenterology Associates</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601-2872</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Franciscan Digestive Care Associates</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exemplar Research, Inc. - Elkins</name>
      <address>
        <city>Elkins</city>
        <state>West Virginia</state>
        <zip>26241</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Favaloro</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1093AAS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado Centro Médico de Córdoba</name>
      <address>
        <city>Córdoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio 9 de Julio SA</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Hospital Brisbane</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne - PPDS</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>A.ö. Krankenhaus der Barmherzigen Brüder</name>
      <address>
        <city>St. Veit an der Glan</city>
        <state>Kärnten</state>
        <zip>9300</zip>
        <country>Austria</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum St. Pölten</name>
      <address>
        <city>St. Pölten</city>
        <state>Saint Pölten</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-Universitätsklinikum Klinikum Graz</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt Am Woerthersee</name>
      <address>
        <city>Klagenfurt am Wörthersee</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salzburger Landeskliniken</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Wien (Medical University of Vienna)</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <state>West-Vlaanderen</state>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mouscron</name>
      <address>
        <city>Mouscron</city>
        <zip>7700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Banja Luka</name>
      <address>
        <city>Banja Luka</city>
        <zip>78000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Sveta Anna</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1750</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Eurohospital</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center-1-Sevlievo EOOD</name>
      <address>
        <city>Sevlievo</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Multiprofile Hospital for Active Treatment Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Excelsior OOD - PPDS</name>
      <address>
        <city>Sofia</city>
        <zip>1421</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic and Consulting Center Aleksandrovska EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Convex EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1680</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consultative Centre Mladost - M OOD</name>
      <address>
        <city>Varna</city>
        <zip>9020</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Percuro Clinical Research LTD</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8P 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Digestive Disease Associates Inc</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3N 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobón Uribe</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servimed S.A.S</name>
      <address>
        <city>Bucaramanga</city>
        <state>Santander</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Centro Médico Julián Coronel S.A.S. - PPDS</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Center Zagreb</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opca Bolnica Karlovac</name>
      <address>
        <city>Karlovac</city>
        <state>Karlovacka Županija</state>
        <zip>47000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opca bolnica Bjelovar</name>
      <address>
        <city>Bjelovar</city>
        <zip>43000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Centre Osijek</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Split</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Virovitica</name>
      <address>
        <city>Virovitica</city>
        <zip>33000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General County Hospital Vukovar and Croatian Veterans Hospital</name>
      <address>
        <city>Vukovar</city>
        <zip>32000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Zadar</name>
      <address>
        <city>Zadar</city>
        <zip>23 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hepato-Gastroenterologie HK, s. r. o.</name>
      <address>
        <city>Hradec Králové</city>
        <state>Královéhradecký Kraj</state>
        <zip>500 12</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PreventaMed s.r.o.</name>
      <address>
        <city>Olomouc</city>
        <state>Olomoucký Kraj</state>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Klinicke A Experimentalni Mediciny</name>
      <address>
        <city>Praha 4</city>
        <zip>140 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISCARE I.V.F. a.s.</name>
      <address>
        <city>Praha 7</city>
        <zip>170 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>401 13</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice</name>
      <address>
        <city>Ústi Nad Orlici</city>
        <zip>562 18</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Viru Central Hospital</name>
      <address>
        <city>Kohta-Järve</city>
        <zip>31025</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OÜ LV Venter</name>
      <address>
        <city>Parnu</city>
        <zip>80010</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Tallinn Central Hospital</name>
      <address>
        <city>Tallinn</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum der RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Campus Research GbR</name>
      <address>
        <city>Münster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <state>Thüringen</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Facharztpraxis am Mexikoplatz</name>
      <address>
        <city>Berlin-Zehlendorf</city>
        <zip>14163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Klinikum Biberach</name>
      <address>
        <city>Biberach an der Riss</city>
        <zip>88400</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Westklinikum Hamburg Ggmbh</name>
      <address>
        <city>Hamburg</city>
        <zip>22559</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isa der Technischen Universitaet Muenchen</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ippokrateio General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Theageneio Anticancer Oncology Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54007</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedica - PPDS</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvédség Egészségügyi Központ</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pannónia Magánorvosi Centrum Kft</name>
      <address>
        <city>Budapest</city>
        <zip>1136</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENDOMEDIX Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1139</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz</name>
      <address>
        <city>Békéscsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mohacsi Korhaz</name>
      <address>
        <city>Mohacs</city>
        <zip>7700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolna Megyei Balassa János Kórház</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csongrad Megyei Dr. Bugyi Istvan Korhaz</name>
      <address>
        <city>Szentes</city>
        <zip>6600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csolnoky Ferenc Korhaz</name>
      <address>
        <city>Veszprém</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jávorszky Ödön Kórház</name>
      <address>
        <city>Vác</city>
        <zip>2600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center - PPDS</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nazareth EMMS Hospital</name>
      <address>
        <city>Nazareth</city>
        <zip>16100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center PPDS</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baruch Padeh Poriya Medical Center</name>
      <address>
        <city>Tiberias</city>
        <zip>15208</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Mater Domini Di Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Modena Policlinico</name>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Casa Sollievo Della Sofferenza IRCCS</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Puglia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Sacro Cuore Don Calabria</name>
      <address>
        <city>Negrar</city>
        <state>Veneto</state>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Maggiore della Carità</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo di Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Sapienza-Università di Roma-Policlinico Umberto I</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano (MI)</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ordine Mauriziano di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaidô</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Aoyama Clinic</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyôgo</state>
        <zip>650-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine</name>
      <address>
        <city>Nishinomiya-shi</city>
        <state>Hyôgo</state>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sagamihara Kyodo Hospital</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <zip>252-5188</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihonbashi Egawa Clinic</name>
      <address>
        <city>Chuo-Ku</city>
        <state>Tokyo</state>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jikei University Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Kitasato Institute Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>108-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ome Municipal General Hospital</name>
      <address>
        <city>Ome</city>
        <state>Tokyo</state>
        <zip>198-0042</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokatsu Tsujinaka Hospital</name>
      <address>
        <city>Abiko</city>
        <zip>270-1166</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kunimoto Hospital</name>
      <address>
        <city>Asahikawa</city>
        <zip>070-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Chikushi Hospital</name>
      <address>
        <city>Chikushino</city>
        <zip>818-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hakodate Koseiin Hakodate Goryoukaku Hospital</name>
      <address>
        <city>Hakodate</city>
        <zip>040-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawabe Clinic</name>
      <address>
        <city>Koganei</city>
        <zip>184-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuai Memorial Hospital</name>
      <address>
        <city>Koga</city>
        <zip>306-0232</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hidaka Coloproctology Clinic</name>
      <address>
        <city>Kurume-shi</city>
        <zip>839-0809</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aizawa Hospital</name>
      <address>
        <city>Matsumoto-shi</city>
        <zip>390-0814</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute</city>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nishinomiya Municipal Central Hospital</name>
      <address>
        <city>Nishinomiya</city>
        <zip>663-8014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishida Clinic of IBD and Gastroenterology</name>
      <address>
        <city>Oita</city>
        <zip>870-0823</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onomichi General Hospital</name>
      <address>
        <city>Onomichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinshukai Infusion Clinic</name>
      <address>
        <city>Osaka-shi</city>
        <zip>530-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiinkai Dojima General &amp; Gastroenterology Clinic</name>
      <address>
        <city>Osaka</city>
        <zip>530-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Otsu-Shi</city>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellland General Hospital</name>
      <address>
        <city>Sakai</city>
        <zip>599-8247</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Sakura</city>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Tokushukai Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>065-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Higashi Tokushukai Hospital</name>
      <address>
        <city>Sapporo</city>
        <zip>065-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku Rosai Hospital</name>
      <address>
        <city>Sendai</city>
        <zip>981-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital</name>
      <address>
        <city>Shimotsuga-gun</city>
        <zip>321-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital</name>
      <address>
        <city>Takatsuki</city>
        <zip>569-0086</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koukokukai Ebisu Clinic</name>
      <address>
        <city>Tokyo</city>
        <zip>150-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinbeppu Hospital</name>
      <address>
        <city>Beppu</city>
        <state>Ôita</state>
        <zip>874-0833</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yodogawa Christian Hospital</name>
      <address>
        <city>Osaka</city>
        <state>Ôsaka</state>
        <zip>533-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <state>Daegu Gwang'yeogsi</state>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju</city>
        <state>Gang'weondo</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>702-210</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03181</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Seoul Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>100-032</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rafik Hariri University Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammoud Hospital University Medical Center</name>
      <address>
        <city>Saida</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kaunas Clinics</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros Klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>LT- 08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius City Clinical Hospital</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-10207</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Higado y Gastroenterologia Integral, S.C.</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62170</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JM Research S.C</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Atencion Medica e Investigacion en Salud</name>
      <address>
        <city>Merida</city>
        <state>Yucatán</state>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Médica Aguascalientes</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20116</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phylasis Clinicas Research S. de R.L. de C.V.</name>
      <address>
        <city>Cuautitlán Izcalli</city>
        <zip>54769</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Clinica Acelerada, S.C.</name>
      <address>
        <city>Distrito Federal</city>
        <zip>07020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Aplicadas a la Neurociencia A.C.</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelerium, S. de R.L. de C.V.</name>
      <address>
        <city>Monterrey</city>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Tlalnepantla De Baz</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.</name>
      <address>
        <city>Zapopan</city>
        <zip>45030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ETZ-Elisabeth</name>
      <address>
        <city>Tilburg</city>
        <state>Noord-Brabant</state>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NWZ, location Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <state>Noord-Holland</state>
        <zip>1815 JD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <state>South Island</state>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Newtown</city>
        <state>Wellington</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <zip>3240</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melita Medical</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>50-449</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexmedica</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>53-114</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitamed Galaj i Cichomski sp.j.</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj</name>
      <address>
        <city>Torun</city>
        <state>Kujawsko-pomorskie</state>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.</name>
      <address>
        <city>Wloclawek</city>
        <state>Kujawsko-pomorskie</state>
        <zip>87-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny</name>
      <address>
        <city>Lódz</city>
        <state>Lódzkie</state>
        <zip>90-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow</name>
      <address>
        <city>Lódz</city>
        <state>Lódzkie</state>
        <zip>90-647</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Centrum Zdrowia Matki Polki</name>
      <address>
        <city>Lódz</city>
        <state>Lódzkie</state>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowskie Centrum Medyczne</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioVirtus Centrum Medyczne</name>
      <address>
        <city>Jozefow</city>
        <state>Mazowieckie</state>
        <zip>05-410</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zakład Opieki Zdrowotnej VIVAMED</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>03-580</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miedzyleski Szpital Specjalistyczny w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>04-749</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Bialymstoku</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoskopia Sp. z o.o.</name>
      <address>
        <city>Sopot</city>
        <state>Pomorskie</state>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii</name>
      <address>
        <city>Konskie</city>
        <state>Swietokrzyskie</state>
        <zip>26-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia - Szczecińskie Centrum Medyczne</name>
      <address>
        <city>Szczecin</city>
        <state>Zachodniopomorskie</state>
        <zip>71-434</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Bydgoszcz</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Czestochowa - PRATIA - PPDS</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Gdynia - PRATIA - PPDS</name>
      <address>
        <city>Gdynia</city>
        <zip>81-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ All Medicus</name>
      <address>
        <city>Katowice</city>
        <zip>40-659</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska</name>
      <address>
        <city>Krakow</city>
        <zip>31-315</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.</name>
      <address>
        <city>Ksawerow</city>
        <zip>95-054</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Gastr Sp.z.o.o Sp.k</name>
      <address>
        <city>Lodz</city>
        <zip>91-034</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia - Centrum Medyczne Nowa Sol</name>
      <address>
        <city>Nowa Sól</city>
        <zip>67-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Innowacyjnych Terapii</name>
      <address>
        <city>Piaseczno</city>
        <zip>05-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa</name>
      <address>
        <city>Poznan</city>
        <zip>60-856</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korczowski Bartosz, Gabinet Lekarski</name>
      <address>
        <city>Rzeszow</city>
        <zip>35-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bandurskiego 98/U12</name>
      <address>
        <city>Szczecin</city>
        <zip>71-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sonomed Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>71-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H-T. Centrum Medyczne Endoterapia</name>
      <address>
        <city>Tychy</city>
        <zip>43-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia MDM</name>
      <address>
        <city>Warszawa</city>
        <zip>00-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Warszawa - PRATIA - PPDS</name>
      <address>
        <city>Warszawa</city>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSW</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II</name>
      <address>
        <city>Zamosc</city>
        <zip>22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz</name>
      <address>
        <city>Lisbon</city>
        <state>Lisboa</state>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Algarve - Hospital de Portimao</name>
      <address>
        <city>Faro</city>
        <zip>8000-385</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Senhora da Oliveira - Guimaraes, E.P.E</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de São Bernardo</name>
      <address>
        <city>Setubal</city>
        <zip>2910-446</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cluj-Napoca Emergency Clinical County Hospital</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr.Carol Davila Emergency University Central Military Hospital</name>
      <address>
        <city>Bucharest</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Monitoring SRL</name>
      <address>
        <city>Bucharest</city>
        <zip>011025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colentina Clinical Hospital</name>
      <address>
        <city>Bucharest</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prof. Dr. Matei Bals Institute of Infectious Diseases</name>
      <address>
        <city>Bucharest</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundeni Clinical Institute</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul Medical Hifu Terramed Conformal S.R.L.</name>
      <address>
        <city>Bucuresti</city>
        <zip>031864</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Romania SRL</name>
      <address>
        <city>Constanta</city>
        <zip>RO-900591</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromedica SRL</name>
      <address>
        <city>Iasi</city>
        <zip>700506</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Tirnaveanu Amelita Private Practice</name>
      <address>
        <city>Oradea</city>
        <zip>410066</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Goldis Gastroenterology Center SRL</name>
      <address>
        <city>Timisoara</city>
        <zip>300002</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University</name>
      <address>
        <city>Kazan</city>
        <zip>420097</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Clinical Scientific Center</name>
      <address>
        <city>Moscow</city>
        <zip>111123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Regional Research Clinical Institute Na Mfvladimirskiy</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhegorodskaya Regional Clinical Hospital n.a. Semashko</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Physiology and Basic Medicine</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630117</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov State Medical University</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov State Medical University</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Clinic, LLC</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Medical Military Academy n.a. S.M. Kirov</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Reaviz</name>
      <address>
        <city>Samara</city>
        <zip>443011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city</name>
      <address>
        <city>Samara</city>
        <zip>443029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Company Hepatolog, LLC</name>
      <address>
        <city>Samara</city>
        <zip>443063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHI Regional Clinical Hospital</name>
      <address>
        <city>Saratov</city>
        <zip>410012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smolensk Regional Clinical Hospital</name>
      <address>
        <city>Smolensk</city>
        <zip>214018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Municipal Clinical Hospital</name>
      <address>
        <city>St. Petersburg</city>
        <zip>195257</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First St. Petersburg State Medical University n.a. I.P Pavlov</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavropol State Medical University</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Consulting and Diagnostics Centre</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Bezanijska Kosa</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Nis</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Vrsac</name>
      <address>
        <city>Vrsac</city>
        <zip>26300</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Kragujevac</name>
      <address>
        <city>Kragujevac</city>
        <state>Šumadijski Okrug</state>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitna nemocnica Bratislava</name>
      <address>
        <city>Bratislava</city>
        <zip>851 07</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KM Management, spol. s r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro LM, s.r.o.</name>
      <address>
        <city>Presov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINRESCO, ARWYP Medical Suites</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1619</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. J Breedt</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr JP Wright</name>
      <address>
        <city>Claremont</city>
        <state>Western Cape</state>
        <zip>7708</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. Regional Reina Sofia - PPDS</name>
      <address>
        <city>Cordoba</city>
        <state>Córdoba</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUVI - H.U. Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Teknon - Grupo Quironsalud</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz - PPDS</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio - PPDS</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universität Zürich</name>
      <address>
        <city>Zürich</city>
        <state>Zürich (de)</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mersin University Medical Faculty</name>
      <address>
        <city>Mersin</city>
        <zip>33169</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Municipal Non-profit Enterprise &quot;Chernivtsi Regional Clinical Hospital&quot;</name>
      <address>
        <city>Chernivtsi</city>
        <state>Chernivets'ka Oblast</state>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivs'ka Oblast</state>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <state>Kyïv</state>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnyts'ka Oblast</state>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council</name>
      <address>
        <city>Zaporizhzhia</city>
        <state>Zaporiz'ka Oblast</state>
        <zip>69005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Center Family Medicine Clinic</name>
      <address>
        <city>Dnipro</city>
        <zip>49038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine&quot;</name>
      <address>
        <city>Dnipro</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital</name>
      <address>
        <city>Kharkiv</city>
        <zip>61058</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection</name>
      <address>
        <city>Kharkiv</city>
        <zip>61166</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council</name>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50056</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of LLC Medical Clinic Blagomed</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Hospital #18</name>
      <address>
        <city>Kyiv</city>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Treatment and Diagnostic Center &quot;Healthy and Happy&quot; of LLC &quot;Healthy and Happy&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>01033</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of KRC Kyiv Regional Hospital #2</name>
      <address>
        <city>Kyiv</city>
        <zip>04073</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway</name>
      <address>
        <city>Lviv</city>
        <zip>79007</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE Central City Clinical Hospital of Uzhhorod City Council</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Clinical Research Center of Medical Center LLC Health Clinic</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNPE City Hospital No. 6 of Zaporizhzhia City Council</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary - PPDS</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeen City</state>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield General Hospital - PPDS</name>
      <address>
        <city>Lancashire</city>
        <state>Bury</state>
        <zip>BL9 7TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tyneside General Hospital</name>
      <address>
        <city>North Shields</city>
        <state>Northumberland</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Shrewsbury Hospital</name>
      <address>
        <city>Shrewsbury</city>
        <state>Shropshire</state>
        <zip>SY3 8XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital Edinburgh - PPDS</name>
      <address>
        <city>Edinburh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Gwent Hospital - PPDS</name>
      <address>
        <city>Newport</city>
        <zip>NP20 2UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bosnia and Herzegovina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b5fdf4db2bf003ab47502</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>December 16, 2021</results_first_submitted>
  <results_first_submitted_qc>December 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 14, 2022</results_first_posted>
  <last_update_submitted>December 16, 2021</last_update_submitted>
  <last_update_submitted_qc>December 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcerative colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_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>September 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03290781/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>June 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03290781/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 400 sites from 4 April 2018 (first participant first visit) to 1 July 2021 (last participant last visit). A total of 366 participants were enrolled, randomized and received study treatment.</recruitment_details>
      <pre_assignment_details>Participant with moderate to severe Ulcerative Colitis (UC) who achieved a clinical response and completed their treatment period in the induction studies (either SHP647-301 [NCT03259334] or SHP647-302 [NCT03259308]) were randomized into this study as ontamalimab and placebo responders to receive placebo or ONTA 25 milligrams (mg) or 75 mg.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ONTA 25mg/ Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.</description>
        </group>
        <group group_id="P2">
          <title>ONTA 25mg/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="P3">
          <title>ONTA 75mg/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="P4">
          <title>ONTA 75mg/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="P5">
          <title>Placebo/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="P6">
          <title>Placebo/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="P7">
          <title>Placebo/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="86"/>
                <participants group_id="P4" count="82"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="22"/>
                <participants group_id="P7" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="59"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="19"/>
                <participants group_id="P7" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Relapse</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set consisted of all participants who had received at least 1 dose of Investigational Product (IP) in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).</population>
      <group_list>
        <group group_id="B1">
          <title>ONTA 25mg/ Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B2">
          <title>ONTA 25mg/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B3">
          <title>ONTA 75mg/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B4">
          <title>ONTA 75mg/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B5">
          <title>Placebo/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B6">
          <title>Placebo/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B7">
          <title>Placebo/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="B8">
          <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="73"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="86"/>
            <count group_id="B4" value="82"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="22"/>
            <count group_id="B7" value="21"/>
            <count group_id="B8" value="366"/>
          </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="43.3" spread="15.40"/>
                    <measurement group_id="B2" value="41.2" spread="13.17"/>
                    <measurement group_id="B3" value="42.0" spread="13.81"/>
                    <measurement group_id="B4" value="42.3" spread="14.21"/>
                    <measurement group_id="B5" value="44.7" spread="14.16"/>
                    <measurement group_id="B6" value="40.9" spread="9.42"/>
                    <measurement group_id="B7" value="39.9" spread="12.10"/>
                    <measurement group_id="B8" value="42.1" spread="13.75"/>
                  </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="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="35"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="82"/>
                    <measurement group_id="B4" value="74"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="20"/>
                    <measurement group_id="B8" value="337"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <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 group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="312"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Remission Based on Composite Score at Week 52</title>
        <description>Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25 mg/ Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25 mg/ONTA 25 mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75 mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75 mg/ONTA 75 mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Composite Score at Week 52</title>
          <description>Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
          <population>The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="33"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.451</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.296</ci_lower_limit>
            <ci_upper_limit>0.572</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.278</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.142</ci_lower_limit>
            <ci_upper_limit>0.401</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Endoscopic Remission at Week 52</title>
        <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Endoscopic Remission at Week 52</title>
          <description>Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="40"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.463</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.310</ci_lower_limit>
            <ci_upper_limit>0.585</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.339</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.197</ci_lower_limit>
            <ci_upper_limit>0.463</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Remission at Week 52</title>
        <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Remission at Week 52</title>
          <description>Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="42"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.497</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.337</ci_lower_limit>
            <ci_upper_limit>0.620</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.294</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.148</ci_lower_limit>
            <ci_upper_limit>0.425</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sustained Remission at Week 52</title>
        <description>Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Remission at Week 52</title>
          <description>Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood &amp; 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="22"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.277</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.129</ci_lower_limit>
            <ci_upper_limit>0.398</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.191</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.067</ci_lower_limit>
            <ci_upper_limit>0.305</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Response Based on Composite Score at Week 52</title>
        <description>Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or a sub-score for rectal bleeding &lt;= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood &amp; 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Response Based on Composite Score at Week 52</title>
          <description>Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding &gt;=1 point or a sub-score for rectal bleeding &lt;= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood &amp; 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="47"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.488</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.329</ci_lower_limit>
            <ci_upper_limit>0.613</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.343</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.194</ci_lower_limit>
            <ci_upper_limit>0.471</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52</title>
        <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52</title>
          <description>Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of &lt;=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="29"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.431</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.280</ci_lower_limit>
            <ci_upper_limit>0.554</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>&lt;0.001</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.227</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.094</ci_lower_limit>
            <ci_upper_limit>0.349</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Glucocorticoid-free Clinical Remission at Week 52</title>
        <description>Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood &amp; 3=blood alone passes).</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Glucocorticoid-free Clinical Remission at Week 52</title>
          <description>Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood &amp; 3=blood alone passes).</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="12"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.176</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.049</ci_lower_limit>
            <ci_upper_limit>0.287</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>&lt;0.005</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion</param_type>
            <param_value>0.111</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.006</ci_lower_limit>
            <ci_upper_limit>0.208</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Glucocorticoid-free Remission at Week 52</title>
        <description>Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Glucocorticoid-free Remission at Week 52</title>
          <description>Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="10"/>
                  </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>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </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>=0.005</p_value>
            <p_value_desc>P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Total Mayo Score at Week 52</title>
        <description>Remission defined as a total mayo score of less than or equal to (&lt;=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Total Mayo Score at Week 52</title>
          <description>Remission defined as a total mayo score of less than or equal to (&lt;=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0</title>
        <description>Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
        <time_frame>At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/ Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0</title>
          <description>Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sustained Endoscopic Remission at Week 52</title>
        <description>Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.</description>
        <time_frame>At Week 52</time_frame>
        <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>PParticipants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Endoscopic Remission at Week 52</title>
          <description>Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.</description>
          <population>The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.</description>
        <time_frame>From start of study drug administration up to follow-up (Week 64)</time_frame>
        <population>The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O6">
            <title>Placebo/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O7">
            <title>Placebo/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.</description>
          <population>The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).</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="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="82"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="22"/>
                <count group_id="O7" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="54"/>
                    <measurement group_id="O4" value="51"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab</title>
        <description>Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.</description>
        <time_frame>At Week 12, 24, 36 and 52</time_frame>
        <population>The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and &quot;number analyzed&quot; refer to the participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>ONTA 25mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>ONTA 25mg/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>ONTA 75mg/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>ONTA 75mg/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Placebo</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo (matched to ontamalimab) subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O6">
            <title>Placebo/ONTA 25mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
          <group group_id="O7">
            <title>Placebo/ONTA 75mg</title>
            <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab</title>
          <description>Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.</description>
          <population>The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and &quot;number analyzed&quot; refer to the participants evaluable at specific time points.</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="72"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="73"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="22"/>
                <count group_id="O7" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="73"/>
                    <count group_id="O5" value="11"/>
                    <count group_id="O6" value="20"/>
                    <count group_id="O7" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="22"/>
                    <count group_id="O7" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="22"/>
                    <count group_id="O7" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to Week 64</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ONTA 25mg/ Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 milligram (mg) of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.</description>
        </group>
        <group group_id="E2">
          <title>ONTA 25mg/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 25 mg of ontamalimab were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="E3">
          <title>ONTA 75mg/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="E4">
          <title>ONTA 75mg/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with 75 mg of ontamalimab were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="E5">
          <title>Placebo/Placebo</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive placebo matched to ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="E6">
          <title>Placebo/ONTA 25mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 25 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
        <group group_id="E7">
          <title>Placebo/ONTA 75mg</title>
          <description>Participants who achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) with placebo were randomized to receive 75 mg of ontamalimab subcutaneously as maintenance treatment using a prefilled syringe once in Q4W up to Week 52.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Clostridium test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Transient global amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder metaplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinitis hypertrophic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="52" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="30" subjects_at_risk="82"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="34" subjects_affected="29" subjects_at_risk="86"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="82"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="82"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290781
org study id: SHP647-303
secondary id: 2017-000573-37
nct id: NCT03290781
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy
      treatment of remission, based on composite score of patient-reported symptoms and centrally
      read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Remission Based on Composite Score at Week 52
time frame: At Week 52
description: Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
measure: Number of Participants With Endoscopic Remission at Week 52
time frame: At Week 52
description: Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
measure: Number of Participants With Clinical Remission at Week 52
time frame: At Week 52
description: Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
measure: Number of Participants With Sustained Remission at Week 52
time frame: At Week 52
description: Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
measure: Number of Participants With Clinical Response Based on Composite Score at Week 52
time frame: At Week 52
description: Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
measure: Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
time frame: At Week 52
description: Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
measure: Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
time frame: At Week 52
description: Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).
measure: Number of Participants With Glucocorticoid-free Remission at Week 52
time frame: At Week 52
description: Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
measure: Number of Participants With Remission Based on Total Mayo Score at Week 52
time frame: At Week 52
description: Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].
measure: Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
time frame: At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
measure: Number of Participants With Sustained Endoscopic Remission at Week 52
time frame: At Week 52
description: Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to follow-up (Week 64)
description: An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
measure: Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
time frame: At Week 12, 24, 36 and 52
description: Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
arm group label: Ontamalimab 25 mg
arm group type: Experimental
description: Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
arm group label: Ontamalimab 75 mg
arm group type: Experimental
description: Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
intervention type: Drug
intervention name: Ontamalimab
description: Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
arm group label: Ontamalimab 25 mg
arm group label: Ontamalimab 75 mg
other name: PF-00547659
other name: SHP647
intervention type: Other
intervention name: Placebo
description: Participants will receive 1 mL of sterile aqueous buffered solution.
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 81 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Shire
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Bosnia and Herzegovina
country: Bulgaria
country: Canada
country: Colombia
country: Croatia
country: Czechia
country: Estonia
country: Germany
country: Greece
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Lebanon
country: Lithuania
country: Mexico
country: Netherlands
country: New Zealand
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Switzerland
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: France
url: https://clinicaltrials.takeda.com/study-detail/5f6b5fdf4db2bf003ab47502
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 