A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)
Last Updated   March 28, 2024 - 21:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
sites -
Status
Recruiting
SUMMARY
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
CONDITIONS
- Colitis, Ulcerative
ELIGIBILITY
Inclusion Criteria:
* Signed informed consent form 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion Criteria:
* Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
* UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
* Presence of a stoma
* Presence or history of fistula
* History of extensive colonic resection (example, <30 cm of colon remaining)
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
DETAILS
LOCATIONS
Country (21) | City or Province (160) | Status |
United States | Atlanta, GA Atlanta Gastroenterology Associates |
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United States | Austin, TX Amel Med LLC. Research |
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United States | Baltimore, MD Mercy Medical Center |
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United States | Bellevue, WA Washington Gastroenterology, PLLC |
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United States | Chapel Hill, NC University North Carolina at Chapel Hill |
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United States | Charlotte, NC Atrium Health |
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United States | Charlotte, NC Charlotte Gastroenterology and Hepatology, PLLC |
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United States | Chesapeake, VA Gastroenterology Associates of Tidewater |
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United States | Colorado Springs, CO Peak Gastroenterology Associates |
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United States | Humble, TX Accurate Clinical Research, Inc. |
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United States | Kissimmee, FL I.H.S. Health. LLC |
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United States | Lubbock, TX Caprock Gastro Research |
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United States | Marrero, LA Tandem Clinical Research |
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United States | New Albany, IN Gastroenterology of Southern Indiana |
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United States | New York, NY New York Gastroenterology Associates |
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United States | North Massapequa, NY DiGiovanna Institute for Medical Education & Research |
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United States | Ogden, UT Care Access Research, Ogden |
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United States | Oklahoma City, OK Digestive Disease Specialists Inc |
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United States | Orange, CA Clinnova Research |
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United States | Orlando, FL Endoscopic Research Inc |
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United States | San Antonio, TX Southern Star Research Institute, LLC |
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United States | San Diego, CA Medical Associates Research Group, Inc. |
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United States | Tacoma, WA Washington Gastroenterology, PLLC |
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United States | Topeka, KS Cotton O'Neil Digestive Health Center |
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United States | Tyler, TX Tyler Research Institute, LLC |
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United States | Westlake, OH Northshore Gastroenterology Research, LLC |
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United Kingdom | Bury Fairfield General Hospital |
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United Kingdom | Cambridge, CAM Addenbrookes Hospital |
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United Kingdom | London Barts Health NHS Trust |
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United Kingdom | London St George's University Hospital NHS Foundation Trust |
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United Kingdom | Oxford, OXF Oxford University Hospitals NHS Foundation Trust |
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United Kingdom | Prescot, MSY Whiston Hospital |
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Turkey | Ankara Gazi University Medical Faculty |
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Turkey | Bursa Uludag Universitesi Tıp Fakultesi Hastanesi |
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Turkey | Izmir Ege Universitesi Tip Fakultesi |
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Turkey | Mersin Mersin University Medical Faculty |
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Spain | Alcorcon, MD Hosp. Univ. Fundacion Alcorcon |
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Spain | Gijon, AS Hosp. de Cabuenes |
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Spain | Madrid, MD Hosp. Univ. La Paz |
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Spain | Majadahonda, MD Hosp. Univ. Pta. de Hierro Majadahonda |
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Spain | Santiago de Compostela Hosp. Clinico Univ. de Santiago |
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Spain | Sevilla Hosp. Ntra. Sra. de Valme |
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Spain | Sevilla Hosp. Virgen Macarena |
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Spain | Valencia, VC Hosp. Clinico Univ. de Valencia |
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Spain | Valencia, VC Hosp. Univ. I Politecni La Fe |
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Spain | Vigo, PO Hosp. Alvaro Cunqueiro |
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South Korea | Busan Inje University Haeundae Paik Hospital |
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South Korea | Daegu Yeungnam University Hospital |
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South Korea | Seoul Asan Medical Center |
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South Korea | Seoul Kangbuk Samsung Hospital |
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South Korea | Seoul Samsung Medical Center |
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South Korea | Seoul Seoul National University Hospital |
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South Korea | Suwon-si, 41 The Catholic university of Korea, St. Vincent's Hospital |
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Romania | Bucuresti S C Delta Health Care S R L |
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Romania | Bucuresti Spital Memorial |
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Romania | Cluj-Napoca Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva |
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Romania | Ploiesti, PH Centrul Medical Valahia |
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Poland | Bydgoszcz Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy |
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Poland | Chojnice Centrum Medyczne Lukamed |
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Poland | Krakow Centrum Medyczne Plejady |
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Poland | Rzeszow Centrum Medyczne Medyk |
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Poland | Szczecin Sonomed Sp. z o.o. |
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Poland | Torun GASTROMED Sp. z o.o. |
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Poland | Warszawa Bodyclinic Sp. z o.o. sp. k |
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Poland | Warszawa Centralny Szpital Kliniczny Mswia |
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Poland | Warszawa Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus |
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Poland | Wroclaw Centrum Medyczne Oporow |
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Poland | Wroclaw EMC Instytut Medyczny SA |
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Poland | Wroclaw Melita Medical Sp. z o.o. |
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Malaysia | Johor Bahru, JH Hospital Sultanah Aminah |
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Malaysia | Kajang, SL Sultan Idris Shah Hospital |
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Malaysia | Kuala Lumpur University Malaya Medical Centre |
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Japan | Fujiidera-shi, 27 Sai Clinic, Gastrointestinal and Protology Divisions |
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Japan | Hamamatsu Hamamatsu University Hospital |
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Japan | Kagoshima Kagoshima IBD Gastroenterology Clinic |
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Japan | Kashiwa Tsujinaka Hospital Kashiwanoha |
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Japan | Kobe, 28 Aoyama Naika Clinic |
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Japan | Osaka, 27 Japanese Red Cross Osaka Hospital |
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Japan | Osaka, 27 Kinshukai Infusion Clinic |
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Japan | Sakura Toho University Sakura Medical Center |
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Japan | Sapporo, 01 Sapporo Higashi Tokushukai Hospital |
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Japan | Sapporo, 01 Sapporo Tokushukai Hospital |
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Japan | Shimizu National Hospital Organization Shizuoka Medical Center |
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Japan | Tsu Mie University Hospital |
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Japan | Yokohama, 14 Yokohama City University Medical Center |
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Italy | Milano Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano |
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Italy | Milano Ospedale San Raffaele di Milano |
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Italy | Negrar Di Valpolicella Ospedale Sacro Cuore Don Calabria |
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Italy | Roma Azienda Ospedaliera San Camillo - Roma |
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Italy | Roma Fondazione Policlinico Universitario A Gemelli IRCCS |
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Italy | Rozzano Istituto Clinico Humanitas |
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Italy | San Giovanni Rotondo Casa Sollievo della Sofferenza, IRCCS |
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India | Jaipur, RJ S. R. Kalla Memorial General Hospital |
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India | Surat, GJ SIDS Hospital & Research Centre |
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Hungary | Budapest Pannónia Magánorvosi Centrum Kft |
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Hungary | Budapest Semmelweis Egyetem |
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Hungary | Budapest Semmelweis Egyetem |
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Hungary | Debrecen Debreceni Egyetem Gasztroenterologiai Klinika |
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Hungary | Debrecen Vasutegeszsegugyi Nonprofit Kozhasznu Kft. |
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Hungary | Gyongyos Clinexpert Kft |
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Germany | Augsburg Klinikum Augsburg |
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Germany | Berlin, BE Krankenhaus Waldfriede Mitte |
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Germany | Dresden, SN Universitaetsklinikum Carl Gustav Carus TU Dresden |
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Germany | Kiel, SH Universitatsklinikum Schleswig Holstein Kiel |
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Germany | Leipzig Eugastro GmbH |
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Germany | Lueneburg, NI Staedtisches Klinikum Lueneburg |
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Germany | Minden Gastroenterologische Gemeinschaftspraxis Minden |
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France | Besancon Cedex CHRU Besancon Hopital Jean Minjoz |
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France | Creteil APHP - Hopital Henri Mondor |
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France | Lille CHRU de Lille - Hopital Claude Huriez |
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France | Nice CHU de Nice Hopital de l Archet |
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France | Nimes Cedex CHU Nimes Hopital Caremeau |
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France | Paris APHP - Hopital Bichat - Claude Bernard |
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France | Pierre Benite Hospices Civils de Lyon CHU Lyon Sud |
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France | Saint Priest en Jarez CHU Saint-Etienne - Hopital Nord |
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France | Toulouse CHU Toulouse - Hopital de Rangueil |
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France | Vandœuvre-les-Nancy CHU de Nancy_ Hopital Brabois |
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Czechia | Ceske Budejovice Nemocnice Ceske Budejovice |
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Czechia | Hradec Kralova Gastroenterologie, s.r.o., Hradec Kralove |
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Czechia | Hradec Kralove Hepato-gastroenterologie HK, s.r.o. |
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Czechia | Praha ISCARE a.s. |
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Czechia | Slany Nemocnice Slany |
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China | Changsha The second Xiangya Hospital of Central South University |
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China | Chongqing, 97 Chongqing General Hospital |
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China | Guangzhou The First Affiliated Hospital, Sun Yat-sen University |
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China | Guangzhou The Sixth Affiliated Hospital Sun Yat sen University |
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China | Hangzhou Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
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China | Jinan Qilu Hospital of Shandong University |
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China | Lan Zhou Lanzhou University Second Hospital |
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China | Nan Jing Shi Nanjing Drum Tower Hospital |
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China | Shen Yang Shi Shengjing Hospital of China Medical University |
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China | Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology |
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China | Wuxi Wuxi People s Hospital |
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China | Xi'An The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital |
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Canada | Barrie, ON Barrie GI Associates |
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Canada | Edmonton, AB Gastroenterology and Internal Medicine Research Institute (GIRI) |
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Canada | London, ON London Health Sciences Centre |
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Canada | Oakville, ON ABP Research Services Corp. |
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Brazil | Botucatu UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu |
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Brazil | Brasília L2IP Instituto de Pesquisas Clinicas |
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Brazil | Curitiba, PR CDC - Centro Digestivo de Curitiba |
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Brazil | Santo Andre, SP Pesquisare Saude |
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Brazil | Sao Paulo, SP BR TRIALS-Ensaios Clinicos e Consultoria Ltda |
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Brazil | Sao Paulo, SP Instituto D Or de Pesquisa e Ensino |
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Brazil | Votuporanga, SP INTEGRAL Pesquisa e Ensino |
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Belgium | Brussels, BRU CHU Saint-Pierre |
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Belgium | Gent AZ Sint-Lucas |
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Belgium | Gent Ghent University Hospital |
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Belgium | Leuven Universitair Ziekenhuis Leuven |
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Belgium | Liege Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman |
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Belgium | Sint-Niklaas Vitaz |
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Australia | Birtinya, QLD Sunshine Coast University Hospital |
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Australia | Blacktown, NSW Blacktown Hospital |
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Australia | Concord, NSW Concord Repatriation General Hospital |
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Australia | Wollongong, NSW Wollongong Private Hospital |
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Argentina | Buenos Aires, B Cer Instituto Medico |
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Argentina | Buenos Aires, B Gedyt - Consultorios Gastroenterologia |
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Argentina | Ciudad Autonoma de Buenos Aires, B CIPREC |
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Argentina | Rosario Hospital Provincial del Centenario |
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Argentina | San Miguel de Tucuman Sanatorio 9 de Julio |
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