<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/NCT03283085</url>
  </required_header>
  <id_info>
    <org_study_id>SHP647-304</org_study_id>
    <secondary_id>2017-000574-11</secondary_id>
    <nct_id>NCT03283085</nct_id>
  </id_info>
  <brief_title>A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)</brief_title>
  <official_title>A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of long-term treatment&#xD;
      with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's&#xD;
      disease (CD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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 Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) are defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. The TEAEs will be further categorized based on severity as mild (may require only minimal treatment) to severe (may require intensive therapeutic intervention).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Infections</measure>
    <time_frame>Baseline upto 12 weeks post EOT (upto a maximum of 3 years)</time_frame>
    <description>Number of participants with serious infections will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event</measure>
    <time_frame>Baseline upto 12 weeks post EOT (upto a maximum of 3 years)</time_frame>
    <description>Clinical laboratory assessments include hematology, serum chemistry and urinalysis. Any clinically significant change in the clinical laboratory value from baseline will be recorded as an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event</measure>
    <time_frame>Baseline upto EOT (upto a maximum of 3 years)</time_frame>
    <description>12-lead ECG will be recorded. Any clinically significant change in ECG will be recorded as an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event</measure>
    <time_frame>Baseline upto 12 weeks post EOT (upto a maximum of 3 years)</time_frame>
    <description>Vital sign assessments include blood pressure, pulse, respiratory rate and temperature. Any clinically significant change in vital signs from baseline will be recorded as an AE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Ulcerative Colitis with Treatment Response Over Time</measure>
    <time_frame>Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)</time_frame>
    <description>Treatment response over time is defined as clinical composite score that has decreased by greater than or equal to (&gt;or= 2) points and &gt;or=30 percentage (%), with an accompanying decrease in the sub score for RB &gt;or= 1 point or a subscore for rectal bleeding (RB) &gt;or=1, and/or composite score that has decreased by &gt;or= 30% and &gt;or=3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Crohn's Disease with Treatment Response Over Time</measure>
    <time_frame>Baseline upto 12 weeks post EOT (upto a maximum of 3 years)</time_frame>
    <description>Treatment response over time defined as CDAI score that has decreased &gt;or= 100 points compared to baseline value for induction studies and/or simple endoscopic score for Crohn's disease (SES-CD) that has decreased by &gt;or= 25% compared to baseline value for induction studies. SES-CD is simple scoring system based on 4 endoscopic variables measured in same 5 ileocolonic segments as Crohn's disease index of severity. Overall values on SES-CD range from 0-56, with higher values indicating more severe disease. 4 endoscopic variables are scored from 0-3 in each bowel segment: ileum, right/transverse/left colon, rectum. Presence and size of ulcers (none= score 0; diameter 0.1-0.5centimetre(cm)= score 1; 0.5-2cm= score 2; diameter &gt;2cm= score 3); extent of ulcerated surface (none= 0; &lt;10%=1; 10%-30%= 2; &gt;30%= 3); extent of affected surface (none= 0; &lt;50%= 1; 50%-75%= 2; &gt;75%= 3); Presence and type of narrowing (none=0; single can be passed=1; multiple can be passed=2; cannot be passed=3).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">557</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>25 mg Ontamalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>75 mg Ontamalimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>25 mg Ontamalimab</intervention_name>
    <description>Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.</description>
    <arm_group_label>25 mg Ontamalimab</arm_group_label>
    <other_name>PF-00547659</other_name>
    <other_name>SHP647</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>75 mg Ontamalimab</intervention_name>
    <description>Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.</description>
    <arm_group_label>75 mg Ontamalimab</arm_group_label>
    <other_name>SHP647</other_name>
    <other_name>PF-00547659</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants with Ulcerative Colitis (UC):&#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 been enrolled previously in study SHP647-301 (NCT03259334),&#xD;
             SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303,&#xD;
             completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303&#xD;
             (NCT03290781), had responded to ontamalimab treatment (in the induction and/or&#xD;
             maintenance studies), and meet one of the following criteria:&#xD;
&#xD;
             a. Participants are on placebo at the maintenance study ET or Week 52 visit: they&#xD;
             received ontamalimab in the induction studies and fulfilled the maintenance study&#xD;
             response criteria, OR b. Participants have received ontamalimab at the maintenance&#xD;
             study ET or Week 52 visit: i) Clinical composite score that has decreased by &gt;or=2&#xD;
             points and &gt;or=30%, with an accompanying decrease in the subscore for RB &gt;or=1 point&#xD;
             or a subscore for RB &lt;or=1, compared to the baseline value for induction studies,&#xD;
             and/or ii) Composite score that has decreased by &gt;or=30% and &gt;or=3 points compared to&#xD;
             the baseline value for induction studies.&#xD;
&#xD;
          -  Participants receiving any treatment(s) for UC are eligible provided they have been on&#xD;
             a stable dose for the designated period of time.&#xD;
&#xD;
        Participants with Crohn's Disease:&#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 been enrolled previously in Study SHP647-305 (NCT03559517) or&#xD;
             SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307&#xD;
             (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had&#xD;
             responded to ontamalimab treatment (in the induction or maintenance studies) and meet&#xD;
             one of the following criteria:&#xD;
&#xD;
               1. Participants are on placebo at the maintenance study ET or Week 52 visit: they&#xD;
                  received ontamalimab in the induction study and fulfilled the maintenance study&#xD;
                  response criteria, OR&#xD;
&#xD;
               2. Participants have received ontamalimab at the maintenance study ET or Week 52&#xD;
                  visit:&#xD;
&#xD;
             i) CDAI score that has decreased by &gt;or=100 points at EOT visit compared to the&#xD;
             baseline value for induction studies, and/or ii) SES-CD that has decreased by &gt;or=25%&#xD;
             compared to the baseline value for induction studies.&#xD;
&#xD;
          -  Participants receiving any treatment(s) for CD are eligible provided they have been on&#xD;
             a stable dose for the designated period of time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants with UC:&#xD;
&#xD;
          -  Participants who had major protocol deviation(s) (as determined by the sponsor) in&#xD;
             study SHP647-301, SHP647-302, or SHP647-303.&#xD;
&#xD;
          -  Participants who permanently discontinued investigational product because of an AE,&#xD;
             regardless of relatedness to investigational product, in study SHP647-301, SHP647-302,&#xD;
             or SHP647-303.&#xD;
&#xD;
          -  Participants who are likely to require major surgery for UC.&#xD;
&#xD;
          -  Participants are females who became pregnant during study SHP647-301, SHP647-302, or&#xD;
             SHP647-303, females who are lactating, females who are planning to become pregnant&#xD;
             during the study period, or males or females of childbearing potential not agreeing to&#xD;
             continue using appropriate contraception methods (i.e. highly effective methods for&#xD;
             female and medically appropriate methods for male study participants) through the&#xD;
             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 [e.g.], renal, hepatic, hematologic, gastrointestinal&#xD;
             [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g.&#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 ECG abnormality that may increase the risk associated with study&#xD;
             participation or investigational product administration or may interfere with the&#xD;
             interpretation of study results and, in the judgment of the investigator, would make&#xD;
             the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at&#xD;
             screening in study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have&#xD;
             been advised to require treatment for latent or active disease, but who are without a&#xD;
             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 other investigational studies (other than&#xD;
             SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational&#xD;
             studies during long-term extension study SHP647-304.&#xD;
&#xD;
        Participants with Crohn's Disease:&#xD;
&#xD;
          -  Participants who had major protocol deviation(s) (as determined by the sponsor) in&#xD;
             study SHP647-305, SHP647-306 or SHP647-307.&#xD;
&#xD;
          -  Participants who permanently discontinued investigational product because of an&#xD;
             adverse events (AE), regardless of relatedness to investigational product, in study&#xD;
             SHP647-305, SHP647-306 or SHP647-307.&#xD;
&#xD;
          -  Participants who are likely to require major surgery for CD or developed acute severe&#xD;
             complications of CD (with or without fulfilling the treatment failure criteria in the&#xD;
             maintenance study) that required immediate intervention (e.g. need for immediate&#xD;
             biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI)&#xD;
             score more than (&gt;) 450.&#xD;
&#xD;
          -  Participants are females who became pregnant during study SHP647-305, SHP647-306 or&#xD;
             SHP647-307, females who are lactating, females who are planning to become pregnant&#xD;
             during the study period, or males or females of childbearing potential not agreeing to&#xD;
             continue appropriate contraception methods (i.e. highly effective methods for female&#xD;
             and medically appropriate methods for male study participants) through the conclusion&#xD;
             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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 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>Arizona Digestive Health</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CATS Research Center - University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</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>Tibor Rubin VA Medical Center - NAVREF</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</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>
    </facility>
  </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>
      <address>
        <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>
      </address>
    </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>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Network</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Group of Naples</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharma Research International Inc</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayside Clinical Research - New Port Richey</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Consultants LLC - Clinedge - PPDS</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - St. Petersburg - ERN - PPDS</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BRCR Medical Center, Inc</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33322</zip>
        <country>United States</country>
      </address>
    </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>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DBC Research</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </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>
      </address>
    </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>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinite Clinical Trials</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Specialists, PC</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </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>60041</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>Cotton O'Neil Clinical Research Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</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>DelRicht Clinical Research, LLC - ClinEdge - PPDS</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</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, LLC</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical, LLC</name>
      <address>
        <city>Hamtramck</city>
        <state>Michigan</state>
        <zip>48212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Western Michigan, PLC</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System - PPDS</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Gastroenterology PA</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Center PA</name>
      <address>
        <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>
  </location>
  <location>
    <facility>
      <name>Advanced Biomedical Research of America</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </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>
  </location>
  <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>Great Neck</city>
        <state>New York</state>
        <zip>11021</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>Gastro Health Research</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>Penn State Hershey Medical Group</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16803</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>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>Biopharma Informatic 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>Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</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>
  </location>
  <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>
      </address>
    </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>
      </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>Universitätsklinikum St. Pölten</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</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 Leuven- Gasthuisberg Campus</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>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>Medical Center Excelsior OOD - PPDS</name>
      <address>
        <city>Sofia</city>
        <zip>1000</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>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>University Multiprofile Hospital for Active Treatment Sveta Anna</name>
      <address>
        <city>Sofia</city>
        <zip>1709</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consultative Centre Mladost - M OOD</name>
      <address>
        <city>Varna</city>
        <zip>9000</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>Fundación Valle Del Lili</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760026</zip>
        <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>Usti nad Orlici</city>
        <zip>562 18</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OÜ LV Venter</name>
      <address>
        <city>Pärnu</city>
        <state>Pärnumaa</state>
        <zip>80010</zip>
        <country>Estonia</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>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 Heraklion</name>
      <address>
        <city>Heraklion</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iatriko Palaiou Falirou</name>
      <address>
        <city>Paliao Faliro</city>
        <zip>17562</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>
        <zip>Dublin 4</zip>
        <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 (FG)</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</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 Tokushukai Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaidô</state>
        <zip>004-0041</zip>
        <country>Japan</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>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 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>Colo-Proctology Center Matsushima Clinic</name>
      <address>
        <city>Yokohama</city>
        <zip>220-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinbeppu Hospital</name>
      <address>
        <city>Beppu</city>
        <state>Ôita</state>
        <zip>874-8538</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishida Clinic of IBD and Gastroenterology</name>
      <address>
        <city>Oita-city</city>
        <state>Ôita</state>
        <zip>870-0823</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>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>Al Zahraa University Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</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>Centro de Investigacion Clinica Acelerada, S.C.</name>
      <address>
        <city>Tepeyac Insurgentes</city>
        <state>Distrito Federal</state>
        <zip>07020</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>
        <state>Jalisco</state>
        <zip>45030</zip>
        <country>Mexico</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>Accelerium, S. de R.L. de C.V. - PPDS</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64000</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>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>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>Amsterdam UMC - Meibergdreef 9</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>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>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-781</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 SCM</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 Bydgoszcz- PRATIA - PPDS</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 NCM</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>
        <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>Sonomed Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>70-361</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 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 da Luz</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</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>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>Emergency University Hospital</name>
      <address>
        <city>Bucharest</city>
        <zip>050098</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Centrul Medical MEDICUM S.R.L.</name>
      <address>
        <city>Bucuresti</city>
        <zip>031864</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cluj-Napoca Emergency Clinical County Hospital</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</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>St. Elizabeth Municipal Clinical Hospital</name>
      <address>
        <city>St. Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>195257</zip>
        <country>Russian Federation</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>Smoensk</city>
        <zip>214018</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>Clinical Hospital Center Zemun</name>
      <address>
        <city>Zemun</city>
        <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>
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  </location>
  <location>
    <facility>
      <name>CLINRESCO, ARWYP Medical Suites</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1619</zip>
        <country>South Africa</country>
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    </facility>
  </location>
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    <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>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <state>Madrid, Communidad Delaware</state>
        <zip>28007</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28942</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>CHUVI - H.U. Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Centro Medico Teknon - Grupo Quironsalud</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Hospital Universitario Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz - PPDS</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
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  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio - PPDS</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Universität Zürich</name>
      <address>
        <city>Zürich</city>
        <state>Zürich (de)</state>
        <zip>8091</zip>
        <country>Switzerland</country>
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  </location>
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    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Mersin University Medical Faculty</name>
      <address>
        <city>Mersin</city>
        <zip>33169</zip>
        <country>Turkey</country>
      </address>
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    <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>
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  </location>
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    <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>
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    <facility>
      <name>Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnyts'ka Oblast</state>
        <zip>21018</zip>
        <country>Ukraine</country>
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  <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>Municipal Nonprofit Enterprise 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 Specialised 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>
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    </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>Medical Center OK!Clinic+LLC International Institute of Clinical Research</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of LLC Medical Center Dopomoga-Plus</name>
      <address>
        <city>Kyiv</city>
        <zip>02132</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>04073</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>
        <zip>04107</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>MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance</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>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>Aberdeen Royal Infirmary - PPDS</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZN</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/5f6b5fe14db2bf003ab476b8</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunosuppressants</keyword>
  <keyword>Mesalamine</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>Gastroenteritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03283085
org study id: SHP647-304
secondary id: 2017-000574-11
nct id: NCT03283085
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability of long-term treatment
      with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's
      disease (CD)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
description: An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) are defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. The TEAEs will be further categorized based on severity as mild (may require only minimal treatment) to severe (may require intensive therapeutic intervention).
measure: Number of Participants With Serious Infections
time frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
description: Number of participants with serious infections will be assessed.
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event
time frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
description: Clinical laboratory assessments include hematology, serum chemistry and urinalysis. Any clinically significant change in the clinical laboratory value from baseline will be recorded as an AE.
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event
time frame: Baseline upto EOT (upto a maximum of 3 years)
description: 12-lead ECG will be recorded. Any clinically significant change in ECG will be recorded as an AE.
measure: Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event
time frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
description: Vital sign assessments include blood pressure, pulse, respiratory rate and temperature. Any clinically significant change in vital signs from baseline will be recorded as an AE.
measure: Number of Participants with Ulcerative Colitis with Treatment Response Over Time
time frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
description: Treatment response over time is defined as clinical composite score that has decreased by greater than or equal to (>or= 2) points and >or=30 percentage (%), with an accompanying decrease in the sub score for RB >or= 1 point or a subscore for rectal bleeding (RB) >or=1, and/or composite score that has decreased by >or= 30% and >or=3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease.
measure: Number of Participants with Crohn's Disease with Treatment Response Over Time
time frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
description: Treatment response over time defined as CDAI score that has decreased >or= 100 points compared to baseline value for induction studies and/or simple endoscopic score for Crohn's disease (SES-CD) that has decreased by >or= 25% compared to baseline value for induction studies. SES-CD is simple scoring system based on 4 endoscopic variables measured in same 5 ileocolonic segments as Crohn's disease index of severity. Overall values on SES-CD range from 0-56, with higher values indicating more severe disease. 4 endoscopic variables are scored from 0-3 in each bowel segment: ileum, right/transverse/left colon, rectum. Presence and size of ulcers (none= score 0; diameter 0.1-0.5centimetre(cm)= score 1; 0.5-2cm= score 2; diameter >2cm= score 3); extent of ulcerated surface (none= 0; <10%=1; 10%-30%= 2; >30%= 3); extent of affected surface (none= 0; <50%= 1; 50%-75%= 2; >75%= 3); Presence and type of narrowing (none=0; single can be passed=1; multiple can be passed=2; cannot be passed=3).
arm group label: 25 mg Ontamalimab
arm group type: Experimental
description: Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
arm group label: 75 mg Ontamalimab
arm group type: Experimental
description: Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
intervention type: Drug
intervention name: 25 mg Ontamalimab
description: Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.
arm group label: 25 mg Ontamalimab
other name: PF-00547659
other name: SHP647
intervention type: Drug
intervention name: 75 mg Ontamalimab
description: Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.
arm group label: 75 mg Ontamalimab
other name: SHP647
other name: PF-00547659
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 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/5f6b5fe14db2bf003ab476b8
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer