<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/NCT03786380</url>
  </required_header>
  <id_info>
    <org_study_id>3071-305-020</org_study_id>
    <secondary_id>2019-000406-30</secondary_id>
    <nct_id>NCT03786380</nct_id>
  </id_info>
  <brief_title>Diabetic Gastroparesis Study 05</brief_title>
  <official_title>Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label study is to assess the safety of continued treatment with relamorelin for&#xD;
      participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146]&#xD;
      study and to provide treatment for these participants until relamorelin becomes commercially&#xD;
      available or the Sponsor terminates development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The Relamorelin program is being terminated solely based on a business decision.&#xD;
  </why_stopped>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">October 5, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to approximately 22 months</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results</measure>
    <time_frame>Baseline (Day 1) up to approximately 22 months</time_frame>
    <description>Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Meaningful Trends for Vital Signs</measure>
    <time_frame>Up to approximately 22 months</time_frame>
    <description>Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results</measure>
    <time_frame>Up to approximately 22 months</time_frame>
    <description>A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Relamorelin 10 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relamorelin 10 μg</intervention_name>
    <description>Relamorelin 10 μg injected subcutaneously twice daily.</description>
    <arm_group_label>Relamorelin 10 μg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Successful completion of either Study RLM-MD-03 or Study RLM-MD-04&#xD;
&#xD;
          -  Ability to provide written informed consent (IC) prior to any study procedures and&#xD;
             willingness and ability to comply with study procedures&#xD;
&#xD;
          -  Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or&#xD;
             RLM-MD-04, in the opinion of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant is planning to receive an investigational drug (other than study&#xD;
             intervention) or investigational device at any time during Study 3071-305-020&#xD;
&#xD;
          -  Participant has an unresolved adverse event (AE) from a lead-in study, ie, a&#xD;
             clinically significant finding on physical examination, clinical laboratory test, or&#xD;
             12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the&#xD;
             participant's ability to participate in or complete the study&#xD;
&#xD;
          -  Any other reason that, in the investigator's opinion, would confound proper&#xD;
             interpretation of the study or expose a participant to unacceptable risk, including&#xD;
             renal, hepatic, or cardiopulmonary disease&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvy Schneier</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Alabama Research Center, LLC</name>
      <address>
        <city>Athens</city>
        <state>Alabama</state>
        <zip>35611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Specialist of the South East</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G &amp; L Research, LLC</name>
      <address>
        <city>Foley</city>
        <state>Alabama</state>
        <zip>36535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Medical Group, PC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del Sol Research Management, LLC</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Clinical LLC.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adobe Clinical Research LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del Sol Research Management, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Clinical Research Partners</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Applied Research Center of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Gastroenterology</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCP Clinical Research LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinical Research</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GW Research Inc</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</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>Aurora Care Clinic, LLC</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnamics Inc.</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley View Wellness and Medical Center - VVCRD Clinical Research</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</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>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Om Research LLC</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research Institute, Inc.</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tibor Rubin VA Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angel City Research Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</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>Stanford Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriWest Research Associates</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Applications Laboratories, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Associates Research Group, Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syrentis Clinical Research</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upland Clinical Research</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hope Research Development</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peak Gastroenterology Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Esophageal and Stomach Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Fairfield County, P.C.</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Foundation</name>
      <address>
        <city>Bristol</city>
        <state>Connecticut</state>
        <zip>06010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Center of Connecticut, LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visionary Investigators Network</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756-3839</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Research of West Florida, Inc.</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ALL Medical Research LLC</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Research Institute, Inc</name>
      <address>
        <city>Cutler Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Top Medical Research</name>
      <address>
        <city>Cutler Bay</city>
        <state>Florida</state>
        <zip>33189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vida Clinical Trials</name>
      <address>
        <city>Homestead</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nature Coast Clinical Research</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Institute</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cfagi Llc</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panax Clinical Research</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Savin Medical Group LLC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APF Research LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMPM Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Center, Inc.</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>Sensible Healthcare</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Region Clinical Research Institute</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida - Weston</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Associates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River Birch Research Alliance, LLC</name>
      <address>
        <city>Blue Ridge</city>
        <state>Georgia</state>
        <zip>30513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gwinnett Research Institute</name>
      <address>
        <city>Buford</city>
        <state>Georgia</state>
        <zip>30519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Clinical Research, LLC.</name>
      <address>
        <city>Carnesville</city>
        <state>Georgia</state>
        <zip>30521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta LLC</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinite Clinical Trials</name>
      <address>
        <city>Riverdale</city>
        <state>Georgia</state>
        <zip>30274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Diabetes and Osteoporosis Center, PA</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404-7596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Gastroenterology</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</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>Indiana University Health University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Research, LLC</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrated Clinical Trial Services Inc</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Science Research Center</name>
      <address>
        <city>Pratt</city>
        <state>Kansas</state>
        <zip>67124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton-O'Neil Clinical Research Center - Digestive Health</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Professional Research Network of Kansas, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205-1138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Via Christi Clinic, PA</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-State Gastroenterology</name>
      <address>
        <city>Crestview Hills</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners</name>
      <address>
        <city>Bastrop</city>
        <state>Louisiana</state>
        <zip>71220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avant Research Associates LLC</name>
      <address>
        <city>Crowley</city>
        <state>Louisiana</state>
        <zip>70526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cronola LLC</name>
      <address>
        <city>Houma</city>
        <state>Louisiana</state>
        <zip>70630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc. - Lake Charles- 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>Tandem Clinical Research</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Research Institute - Metropolitan Gastroenterology Associates</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America, Inc.</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Gastroenterology Group PC, 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>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodholme Gastroenterology Associates, P.A.</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Clinical Studies, PLLC.</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Research Associates, Inc.</name>
      <address>
        <city>South Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston VA Healthcare System</name>
      <address>
        <city>West Roxbury</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biocon Clinical Research, LLC</name>
      <address>
        <city>Caro</city>
        <state>Michigan</state>
        <zip>48723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aa Mrc, Llc</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</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>Henry Ford Health System</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Troy Gastroenterology, PC dba Center for Digestive Health</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Western Michigan</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MNGI Digestive Health</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montana Medical Research</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Clinical Research, Inc</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of South Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</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>Digestive Disease Specialists</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Test Center 3</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGA Clinical Research Associates, LLC</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lovelace Scientific Resources, Inc.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Gastrointestinal Research Group LLP</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Hospital Center</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Health Services Hospitals, Inc.</name>
      <address>
        <city>Johnson City</city>
        <state>New York</state>
        <zip>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital, Clinical Trials Center</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</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>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Gastroenterology Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Test Center 2</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte, LLC</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Digestive Health Associates, PA</name>
      <address>
        <city>Davidson</city>
        <state>North Carolina</state>
        <zip>28036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Research Associates, LLC</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triad Clinical Trials</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Multispeciality Clinic - Kinston</name>
      <address>
        <city>Kinston</city>
        <state>North Carolina</state>
        <zip>28501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Endocrinology Consultants, PC</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research Salisbury</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Gastroenterology,Inc.</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The MetroHealth System MHS</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109-1998</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease &amp; Surgery Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrinology Research Associates, Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University, Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research, Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hometown Urgent Care and Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Inquest Center Ltd.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research</name>
      <address>
        <city>Wadsworth</city>
        <state>Ohio</state>
        <zip>44281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Specialists Inc</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Clinical Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Options Health Research, LLC</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medical Associates, Research Department</name>
      <address>
        <city>Levittown</city>
        <state>Pennsylvania</state>
        <zip>19056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Endocrinology Associates</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians, Inc.</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guthrie Clinical Research</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research, LLC</name>
      <address>
        <city>Scottdale</city>
        <state>Pennsylvania</state>
        <zip>15683</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montgomery Medical, Inc.</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians, Jacob Murphy</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Partners in Clinical Research, LLC</name>
      <address>
        <city>Cumberland</city>
        <state>Rhode Island</state>
        <zip>02864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates, PA</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinsearch</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</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>Quality Medical Research</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Research Institute, LLC</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avant Research Associates,LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DiscoveResearch, Inc.</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinRx Research, LLC</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences, Center Division of Gastroenterology</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHAT Research Institute</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic Inc., Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rodriguez Clinical Trials</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amir Ali Hassan, MD, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Center of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAGACT PLLC., San Antonio Gastroenterology Associates, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants</name>
      <address>
        <city>Southlake</city>
        <state>Texas</state>
        <zip>76092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute, Inc.</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Test Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verity Research Inc.</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Medical Research</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manassas Clinical Research Centre</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center McGuire VAMC</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Test Center 4</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardinal Internal Medicine</name>
      <address>
        <city>Woodbridge</city>
        <state>Virginia</state>
        <zip>22192</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Gastroenterology PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maffei Centro Medico-Investigacion Clinica Aplicada</name>
      <address>
        <city>C.a.b.a.</city>
        <state>Buenos Aires Province</state>
        <zip>C1425AGC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sirio Libanes</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires Province</state>
        <zip>C1419AHN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIPREC</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires Province</state>
        <zip>1119</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clínicas de Rosario</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de hematología y medicina clínica &quot;Dr. Rubén Dávoli&quot;</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S200CFK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Universitario de Investigacion en Farmacologia Clinic</name>
      <address>
        <city>Corrientes</city>
        <zip>W3402BKE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nepean Hospital</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated</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>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordination</name>
      <address>
        <city>Saint Stefan</city>
        <state>Steiermark</state>
        <zip>8511</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VIVIT Institute, am LKH Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <state>Vorarlberg</state>
        <zip>6800</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privatklinik Wehrle-Diakonissen</name>
      <address>
        <city>Salzburg</city>
        <zip>5026</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oö. Gesundheits- und Spitals-AG/LKH Steyr</name>
      <address>
        <city>Steyr</city>
        <zip>4400</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenanstalt Rudolfstiftung Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH Hietzing</name>
      <address>
        <city>Vienna</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Lucas Brugge</name>
      <address>
        <city>Brugge</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,</name>
      <address>
        <city>Edegem</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Iris Sud - Joseph Bracops</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC - Clinique Saint-Joseph</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Walter Cantídio</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60430-370</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisa Clinica do Brasil</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>71625175</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quanta Diagnóstico e Terapia</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80030-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário João de Barros Barreto - UFPA</name>
      <address>
        <city>Belém</city>
        <state>Para</state>
        <zip>66073-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Vicente de Paulo</name>
      <address>
        <city>Passo Fundo- RS</city>
        <state>Rio Grande Do Sul</state>
        <zip>99010-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90430-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Lucas da PUC-RS</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catarinense de Endocrinologia e Diabetes (ICED)</name>
      <address>
        <city>Joinville</city>
        <state>Santa Catarina</state>
        <zip>89201-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scentryphar Pesquisa Clínica Ltda</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>1302-431</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisa Clínica em Campinas</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13060904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade de Sao Paulo (USP) - Hospital das Clinicas da F</name>
      <address>
        <city>Cerqueira Cesar - Sao Paulo</city>
        <state>Sao Paulo</state>
        <zip>Cep 05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPEC-Instituto de Pesquisa Clinica</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01223-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPQuali Pesquisa Clínica Ltda</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01228-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology</name>
      <address>
        <city>Fortaleza</city>
        <zip>60160-230</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Yuliya Vrevska Byala</name>
      <address>
        <city>Byala</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dobrich AD</name>
      <address>
        <city>Dobrich</city>
        <zip>9300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr. Tota Venkova AD</name>
      <address>
        <city>Gabrovo</city>
        <zip>5300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT - Kaspela- EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Asklepion - Humane Medicine Research EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandrovska University Hospital</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Diabetes Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Health</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>NL A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Medical Arts</name>
      <address>
        <city>Bridgewater</city>
        <state>Nova Scotia</state>
        <zip>B4V 2V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Anil K. Gupta Medicine Professional Corporation</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9V4B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Science Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital, University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISSS de la Monteregie-Centre</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Recherche GCP Research</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1M 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Universite de Montreal - CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Alberta Research Centre</name>
      <address>
        <city>Red Deer</city>
        <zip>T4N 6V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Digestive Disease Associates</name>
      <address>
        <city>Vaughan</city>
        <zip>L4L 4YZ</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rodrigo Botero S.A.S.</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>50030</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiovascular y de Diabetes</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlántico</state>
        <zip>80020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación BIOS</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlántico</state>
        <zip>80020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocare Ltda.</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>111111</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Medical Center</name>
      <address>
        <city>Zipaquirá</city>
        <state>Cundinamarca</state>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medplus Medicina Prepagada</name>
      <address>
        <city>Bogotá</city>
        <state>Distrito Capltal</state>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Imbanaco de Cali S.A.</name>
      <address>
        <city>Cali</city>
        <state>Distrito Capltal</state>
        <zip>760042</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Centro Medico Julian Coronel S.A</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760035</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenheden, Hvidovre hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Kobenhavn</state>
        <zip>2605</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steno Diabetes Center Copenhagen</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjaellands Hospital</name>
      <address>
        <city>Hilleroed</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEA KFA</name>
      <address>
        <city>Aarhus</city>
        <state>Århus</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Hôpital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis-Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corbeil Essonnes</name>
      <address>
        <city>Corbeil Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'hépato-gastroentérologie - 7°D</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Hôpital Edouard Herrriot</name>
      <address>
        <city>LYON Cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Charles Nicolle</name>
      <address>
        <city>Rouen Cedex</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Nancy</name>
      <address>
        <city>Vandoeuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Clinique</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Karlsruhe GmbH</name>
      <address>
        <city>Karlsruhe</city>
        <state>Baden-Württemberg</state>
        <zip>76137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Etzrodt-Walter und Kollegen</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Schwerin GmbH</name>
      <address>
        <city>Schwerin</city>
        <state>Mecklenburg-Western Pomerania</state>
        <zip>19055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologische Schwerpunktpraxis</name>
      <address>
        <city>Bad Berleburg</city>
        <state>North Rhine-Westphalia</state>
        <zip>57319</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Dresden GmbH</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>0 1309</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Schwittay</name>
      <address>
        <city>Böhlen</city>
        <zip>4564</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen und Marburg GmbH</name>
      <address>
        <city>Giessen</city>
        <zip>32392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20253</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22143</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Israelitisches Krankenhaus</name>
      <address>
        <city>Hamburg</city>
        <zip>22297</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hannover-Mitte GmbH</name>
      <address>
        <city>Hannover</city>
        <zip>30159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KRH Klinikum Siloah</name>
      <address>
        <city>Hannover</city>
        <zip>30459</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markhot Ferenc Oktatokorhaz es Rendelointezet</name>
      <address>
        <city>Eger</city>
        <state>Heves</state>
        <zip>H-3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coromed SMO</name>
      <address>
        <city>Pecs</city>
        <state>Pécs</state>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Department of Medicine, University of Szeged</name>
      <address>
        <city>Szeged</city>
        <state>Szaged</state>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zala Megyei Szent Rafael Korhaz</name>
      <address>
        <city>Zalaegerszeg</city>
        <state>Zala</state>
        <zip>H-8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>H-1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stra¡zshegy Medicina</name>
      <address>
        <city>Budapest</city>
        <zip>H1171</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hetenyi Geza Hospital</name>
      <address>
        <city>Szolnok</city>
        <zip>H-5004</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King George Hospital</name>
      <address>
        <city>Visakhapatnam</city>
        <state>Andhra Pradesh</state>
        <zip>530002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zydus Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surat Institute of Digestive Sciences Hospitals</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifecare Clinic and Research Centre - Internal Med/Diabetolo</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560092</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diacon Hospital and research Center</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>359-360</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Hospital Bangalore Medical College and Research Ins</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajalakshmi Hospital</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560097</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinaya Hospital &amp; Research Centre</name>
      <address>
        <city>Mangalore</city>
        <state>Karnataka</state>
        <zip>575003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chopda Medicare &amp; Research Centre Pvt.Ltd, Magnum Heart Institute</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B. J. Government Medical College and Sassoon General Hospitals</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grant Medical Foundation Ruby Hall Clinic</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noble Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.P.Medical College &amp; Group of Hospitals Bikaner</name>
      <address>
        <city>Bikaner</city>
        <state>Rajasthan</state>
        <zip>334003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.R. Kalla Memorial Gastro and General Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sawai Man Singh Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital (SGRH)</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marudhar Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madras Medical College &amp; Rajiv Gandhi Govt. General Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.V. Hospital for Diabetes &amp; Diabetes Research Centre</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kovai Diabetes Speciality Centre</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthur Asirvatham Hospital</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <zip>625020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M V Hospital &amp; Research Centre</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPGME&amp;R and SSKM Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M. S. Ramaiah medical College and Hospitals - Gastroenterolo</name>
      <address>
        <city>Bangalore</city>
        <zip>560054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gleneagles Global Hospital</name>
      <address>
        <city>Hyderabad</city>
        <zip>500004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumudini Devi Diabetes Research Center</name>
      <address>
        <city>Hyderabad</city>
        <zip>500072</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bhatia Hospital</name>
      <address>
        <city>Mumbai</city>
        <zip>400007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion M.C.</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>E. Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Diseases Institute</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Institute</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrinology &amp; Diabetes Center</name>
      <address>
        <city>Safed</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Institute</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milan</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Institute Beato Matteo</name>
      <address>
        <city>Vigevano</city>
        <state>Pavia</state>
        <zip>27029</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo</name>
      <address>
        <city>Rome</city>
        <state>Rome Roma</state>
        <zip>168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cardinal Massaia</name>
      <address>
        <city>Asti</city>
        <zip>14100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bari</name>
      <address>
        <city>Bari</city>
        <zip>70121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi</name>
      <address>
        <city>Catania</city>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Magna Graecia di Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliera Universitaria San Martino</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Napoli Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Opsedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS S.Matteo Hospital Foundation, University of Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pisa - Cisanello Hospital</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gruppo Humanitas - Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita' Di Salerno- Aou Ruggi D'aragona</name>
      <address>
        <city>Salerno</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanggye Paik Hospital, Inje University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>1757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polana-D</name>
      <address>
        <city>Daugavpils</city>
        <zip>5401</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogorelova Jelena GP</name>
      <address>
        <city>Kraslava</city>
        <zip>5601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical University Hospital, Endokrinologijas nodala</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Diseases Centre GASTRO</name>
      <address>
        <city>Riga</city>
        <zip>1006</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sultanah Bahiyah</name>
      <address>
        <city>Alor Setar</city>
        <state>Kedah</state>
        <zip>5460</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universiti Sains Malaysia</name>
      <address>
        <city>Kubang Kerian</city>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Taiping</name>
      <address>
        <city>Taiping</city>
        <zip>34000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinicos Asociados BOCM SC</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>03300</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica OMEGA</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutricion</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Nutritional Trials</name>
      <address>
        <city>México DF</city>
        <state>Distrito Federal</state>
        <zip>6700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Morales Vargas - CIMOVA</name>
      <address>
        <city>León</city>
        <state>Guanajuato</state>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diabetes de Pachuca</name>
      <address>
        <city>Pachuca</city>
        <state>Hidalgo</state>
        <zip>42090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigación Clínica Cardiometabolica de Occidente</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44150</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio Medico</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44210</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigación clínica y atención Médica HEPA S.C.</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44670</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Diabetes Obesidad y Nutrición SC</name>
      <address>
        <city>Cuautla</city>
        <state>Morelos</state>
        <zip>62746</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelerium Clinical Research</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Christus Muguerza Sur</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigación Médica Sonora, S.C.</name>
      <address>
        <city>Hermosillo</city>
        <state>Sonora</state>
        <zip>83280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Especializado en Investigación Clínica S.C.</name>
      <address>
        <city>Boca del Rio</city>
        <state>Veracruz</state>
        <zip>94290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Desarrollo Biomédico</name>
      <address>
        <city>Mérida</city>
        <state>Yucatan</state>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice Dr Gerardo Gonzalez</name>
      <address>
        <city>Acapulco</city>
        <zip>39350</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Cardiológica Aguascalientes</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dioderm Instituto de Investigación</name>
      <address>
        <city>Durango</city>
        <zip>34060</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)</name>
      <address>
        <city>Durango</city>
        <zip>34270</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Metabolismo y Corazón, S.C.</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perpetual Succor Hospital</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Visayas State University Medical Center</name>
      <address>
        <city>IloIlo City</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospital ng Makati</name>
      <address>
        <city>Makati City</city>
        <zip>1218</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manila Doctors Hospital</name>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Juan De Dios Educational Foundation, Inc.</name>
      <address>
        <city>Pasay</city>
        <zip>1300</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Quezon City</city>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardinal Santos Medical Center</name>
      <address>
        <city>San Juan</city>
        <zip>1502</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,</name>
      <address>
        <city>Ystok</city>
        <state>Bia</state>
        <zip>15-879</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Warszawa</name>
      <address>
        <city>Warszawa</city>
        <state>Warazawa</state>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwestytetu Medycznego w Bialymstoku</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nasz Lekarz Osrodek Badan Klinicznych</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-065</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitamed</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Lukamed</name>
      <address>
        <city>Chojnice</city>
        <zip>89-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silmedic Sp z o o</name>
      <address>
        <city>Katowice</city>
        <zip>40 282</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CenterMed Krakow Ltd</name>
      <address>
        <city>Krakow</city>
        <zip>31-530</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczny Gabinet Neurologiczny Marta Banach</name>
      <address>
        <city>Kraków</city>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Medyk</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny w Olsztynie</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-561</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.</name>
      <address>
        <city>Pruszków</city>
        <zip>05-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoskopia SP. Z O.O.</name>
      <address>
        <city>Sopot</city>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Powiatowe Centrum Medyczne w Wołowie</name>
      <address>
        <city>Wołów</city>
        <zip>56-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska</name>
      <address>
        <city>Wrocław</city>
        <zip>51-162</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zamość</name>
      <address>
        <city>Zamość</city>
        <zip>PL 22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Medical Center</name>
      <address>
        <city>Bucharest</city>
        <zip>11025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Endocrinology</name>
      <address>
        <city>Bucharest</city>
        <zip>11863</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMES Research Center SRL</name>
      <address>
        <city>Calarasi</city>
        <zip>910103</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinTrial Medical Center, Pulmonology Department</name>
      <address>
        <city>Dobrosloveni Resca, Olt County</city>
        <zip>237143</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polisano-Clinic</name>
      <address>
        <city>Sibiu</city>
        <zip>550253</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scientific Institute of Clinical and Experimental Lymphology</name>
      <address>
        <city>Novosibirsk</city>
        <state>Novosibirskaya Oblast</state>
        <zip>630117</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North-Western State Medical University named after I. I. Mechnikov</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>191015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millitary-medical Academy, department of hospital therapy</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>191124</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg City Pokrovskaya Hospital</name>
      <address>
        <city>Leningrad Region</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI National medical endocrinology research centre</name>
      <address>
        <city>Moscow</city>
        <zip>117036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Regional Research Clinical Institute named by MF Vladimirski</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko</name>
      <address>
        <city>Nizhny</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov on Don</name>
      <address>
        <city>Rostov on Don</city>
        <zip>344019</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>MUZ City Clinical Hospital 9</name>
      <address>
        <city>Saratov</city>
        <zip>410030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov City Clinical Hospital 12</name>
      <address>
        <city>Saratov</city>
        <zip>410039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119228</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169856</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FARMOVS</name>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto CTC</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1818</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Stanza Clincal Reaserch Centre</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>122</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocare Research</name>
      <address>
        <city>Paarl</city>
        <state>Western Cape</state>
        <zip>7646</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moriana Clinical Research</name>
      <address>
        <city>Brandfort</city>
        <zip>9400</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Helderberg Clinical Research Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TREAD Research</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syenxus Watermeyer Dedicated Research</name>
      <address>
        <city>Val De Grace</city>
        <zip>184</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>20041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Principe de Asturias</name>
      <address>
        <city>Madrid</city>
        <zip>28850</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phramongkutklao Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharaj Nakorn Chiang Mai Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Kryvyi Rih City Hospital #3&quot; of Dnipropetrovsk Regional Council</name>
      <address>
        <city>Dnipropetrovsk Region</city>
        <state>Dnipropetrovs'ka Oblast</state>
        <zip>50002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution Ukrainian State Research Institute</name>
      <address>
        <city>Dnipro</city>
        <state>Dnipropetrovs'ka Oblast</state>
        <zip>49027</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk National Medical University</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <state>Ivano-Frankivs'ka Oblast'</state>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv</name>
      <address>
        <city>Kyiv</city>
        <state>Kyïv</state>
        <zip>1034</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRRI-Vinnytsia National Pirogov Memorial Medical University</name>
      <address>
        <city>Vinnytsya</city>
        <state>Vinnyts'ka Oblast'</state>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution Lutsk City Clinical Hospital</name>
      <address>
        <city>Lutsk</city>
        <state>Volyos'ka Oblast'</state>
        <zip>43024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal nonprofit entity &quot;Chernigiv city hospital #2&quot; of Chernigiv municipal council, therapeutic department</name>
      <address>
        <city>Chernihiv</city>
        <zip>14034</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional municipal institution &quot;Chernivtsi's regional clinical hospital&quot;, gastroenterological department, Higher state educational establishment of Ukraine &quot;Bukovinian state medical university&quot;, department of internal medicine and infectious diseases, c.C</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Public Organization Chernivtsi Regional Endocrinology Center</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine</name>
      <address>
        <city>Dnipro</city>
        <zip>49038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Central City Clinical Hospital</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal nonprofit entity &quot;City clinical hospital #2 n.a. Prof.O.O.Shalimov&quot; of Kharkiv municipal council, department of endocrinology</name>
      <address>
        <city>Kharkiv</city>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;State Institution &quot;National Institute of Therapy named after. L.T. Maloi NAMNU&quot; / Government Institution &quot;L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine&quot;, Department of the study of diseases of the digestive</name>
      <address>
        <city>Kharkiv</city>
        <zip>61039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution Kherson City Clinical Hospital</name>
      <address>
        <city>Kherson</city>
        <zip>73000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company &quot;Medical and Diagnostic Center &quot;ADONIS Plus&quot;, outpatient department, c. Kyiv</name>
      <address>
        <city>Kyiv</city>
        <zip>2002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department</name>
      <address>
        <city>Kyiv</city>
        <zip>3049</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center &quot;Universal Clininc &quot;Oberig&quot; of LLC &quot;Capital&quot;, Gastroenterological Center, c. Kyiv</name>
      <address>
        <city>Kyiv</city>
        <zip>3680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit</name>
      <address>
        <city>Kyiv</city>
        <zip>4050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine</name>
      <address>
        <city>Kyiv</city>
        <zip>4114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital #1, department of endocrinology, c. Mykolayiv</name>
      <address>
        <city>Mykolaiv</city>
        <zip>54003</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University</name>
      <address>
        <city>Odesa</city>
        <zip>65010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Odesa Regional Clinical Hospital&quot;, Out-patient department</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poltava Regional Clinical Hospital</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital</name>
      <address>
        <city>Sumy</city>
        <zip>40031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology</name>
      <address>
        <city>Ternopil</city>
        <zip>46000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Small-Scale Enterprise Medical Center Pulse</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Limited Liability Company &quot;Health Clinic&quot;, Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21009/21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsia Regional Clinical highly specialized Endocrinology Centre</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal nonprofit entity &quot;Vinnytsia's city clinical hospital #1&quot;, gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>6th City Clinical Hospital, c. Zaporizhzhia</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Municipal Institution &quot;&quot;City Hospital #7&quot;&quot;, polyclinic department, c. Zaporizhzhia&quot;</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution-Zaporizhzhia Regional Clinical Hospital</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Oldham Hospital</name>
      <address>
        <city>Oldham</city>
        <state>Lancashire</state>
        <zip>OL1 2JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Research, Exchange House</name>
      <address>
        <city>Cannock</city>
        <state>Staffordshire</state>
        <zip>WS11 0BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of North Midlands</name>
      <address>
        <city>Stoke on Trent</city>
        <state>Staffordshire</state>
        <zip>ST6 8DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Research</name>
      <address>
        <city>Barnsley</city>
        <zip>S75 3DL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research, Kaman Court</name>
      <address>
        <city>Blackpool</city>
        <zip>FY2 0JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Essex Hospital Services NHS Trust Broomfield Hospital</name>
      <address>
        <city>Chelmsford</city>
        <zip>CM1 7ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research, Monarch House</name>
      <address>
        <city>Leeds</city>
        <zip>LS10 1DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Liverpool</city>
        <zip>L34 1BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wingate Institute</name>
      <address>
        <city>London</city>
        <zip>E1 2AJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospita</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9NQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of South Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomedical Research Centre</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research, GAC House</name>
      <address>
        <city>Stockton-on-Tees</city>
        <zip>TS17 6EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>Tooting</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Wolverhampton NHS Trust</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>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Thailand</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Saudi Arabia</country>
  </removed_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>October 5, 2021</results_first_submitted>
  <results_first_submitted_qc>November 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2021</results_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Gastroparesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03786380/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03786380/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants who completed relamorelin studies: RLM-MD-03 [NCT03420781] and RLM-MD-04 [NCT03383146] were eligible to enroll in this open-label safety study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Relamorelin/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week randomized withdrawal period (RWP) of RLM-MD-03.</description>
        </group>
        <group group_id="P2">
          <title>Relamorelin/Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="P3">
          <title>Placebo/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="P4">
          <title>Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="54"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="54"/>
                <participants group_id="P4" count="62"/>
                <participants group_id="P5" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="54"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by the Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="57"/>
                <participants group_id="P5" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled Population included all participants enrolled in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Relamorelin/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="B2">
          <title>Relamorelin/Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="B3">
          <title>Placebo/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="B4">
          <title>Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="54"/>
            <count group_id="B4" value="63"/>
            <count group_id="B5" value="28"/>
            <count group_id="B6" value="202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.0" spread="9.60"/>
                    <measurement group_id="B2" value="63.4" spread="11.87"/>
                    <measurement group_id="B3" value="55.7" spread="10.36"/>
                    <measurement group_id="B4" value="57.3" spread="9.19"/>
                    <measurement group_id="B5" value="58.5" spread="10.44"/>
                    <measurement group_id="B6" value="58.1" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.</description>
        <time_frame>Up to approximately 22 months</time_frame>
        <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Relamorelin/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O2">
            <title>Relamorelin/Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O4">
            <title>Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.</description>
          <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="62"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results</title>
        <description>Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.</description>
        <time_frame>Baseline (Day 1) up to approximately 22 months</time_frame>
        <population>Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Relamorelin/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O2">
            <title>Relamorelin/Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O4">
            <title>Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results</title>
          <description>Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.</description>
          <population>Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="62"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eosinophils Absolute Cell Count [10^9/liter (L)]: &gt;3×Upper Limit of Normal Value (ULN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (RATIO): &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (RATIO): &lt;0.9×Lower Limit of Normal Value (LLN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin [grams (g)/L]: &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes Absolute Cell Count (10^9/L): &gt;1.5×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes Absolute Cell Count (10^9/L): &lt;0.8×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Corpuscular Volume [femtoliter(fL)]: &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils Absolute Cell Count (10^9/L): &gt;1.5×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils Absolute Cell Count (10^9/L): &lt;0.8×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red Blood Cell Count (10^12/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White Blood Cell Count (10^9/L): &lt;0.7×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: &gt;=3×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): &gt;=3×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (HCO3) [millimoles (mmol)/L]: &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (HCO3) (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen (mmol/L): &gt;1.2×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mmol/L): &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol, Total, Fasting (mmol/L): &gt;1.6×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine [micromoles(μmol)/L]: &gt;1.3×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="57"/>
                    <count group_id="O5" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose-Chemistry, Fasting (mmol/L): &gt;2.5×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="53"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose-Chemistry, Fasting (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="53"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glycohemoglobin A1C (%): Increase of &gt;=0.5%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="37"/>
                    <measurement group_id="O5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glycohemoglobin A1C (%): Increase of &gt;=1%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="36"/>
                    <measurement group_id="O5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus (mmol/L): &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="60"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Total (g/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides, Fasting (mmol/L): &gt;=3×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="54"/>
                    <count group_id="O5" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid (Urate) (μmol/L): &gt;1.1×ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid (Urate) (μmol/L): &lt;0.9×LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="43"/>
                    <count group_id="O4" value="47"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Meaningful Trends for Vital Signs</title>
        <description>Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.</description>
        <time_frame>Up to approximately 22 months</time_frame>
        <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Relamorelin/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O2">
            <title>Relamorelin/Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O4">
            <title>Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Meaningful Trends for Vital Signs</title>
          <description>Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.</description>
          <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="62"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results</title>
        <description>A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.</description>
        <time_frame>Up to approximately 22 months</time_frame>
        <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Relamorelin/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O2">
            <title>Relamorelin/Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
          </group>
          <group group_id="O4">
            <title>Relamorelin/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Placebo/Relamorelin</title>
            <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results</title>
          <description>A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.</description>
          <population>Safety Population included all participants who received ≥1 administration of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="62"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 22 months</time_frame>
      <desc>All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Relamorelin/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="E2">
          <title>Relamorelin/Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="E3">
          <title>Placebo/Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.</description>
        </group>
        <group group_id="E4">
          <title>Relamorelin/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Placebo/Relamorelin</title>
          <description>Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA: 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adrenal neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Spinal claudication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA: 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <description>Number at risk is based on the female population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786380
org study id: 3071-305-020
secondary id: 2019-000406-30
nct id: NCT03786380
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This open-label study is to assess the safety of continued treatment with relamorelin for
      participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146]
      study and to provide treatment for these participants until relamorelin becomes commercially
      available or the Sponsor terminates development.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to approximately 22 months
description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
measure: Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
time frame: Baseline (Day 1) up to approximately 22 months
description: Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
measure: Number of Participants With Clinically Meaningful Trends for Vital Signs
time frame: Up to approximately 22 months
description: Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
measure: Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
time frame: Up to approximately 22 months
description: A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
arm group label: Relamorelin 10 μg
arm group type: Experimental
description: Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.
intervention type: Drug
intervention name: Relamorelin 10 μg
description: Relamorelin 10 μg injected subcutaneously twice daily.
arm group label: Relamorelin 10 μg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harvy Schneier
role: Study Director
affiliation: Allergan
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Colombia
country: Denmark
country: France
country: Germany
country: Hungary
country: India
country: Israel
country: Italy
country: Korea, Republic of
country: Latvia
country: Malaysia
country: Mexico
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: South Africa
country: Spain
country: Thailand
country: Ukraine
country: United Kingdom
country: United States
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Gastroparesis
sharing ipd: No
provided document: 
provided document: 
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reported events: 
certain agreements: 
point of contact: 