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NCT05197049Active, not recruitingPhase 3

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

CNTO1959CRD3004: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
350 (actual)
First submitted
17 Jan 2022
Start date
19 Jan 2022
Primary completion date
4 Jul 2023
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05197049
EU CT number
2023-504737-41-00
EudraCT number
2020-006165-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 350
  • From 19 Jan 2022 to the primary completion date, 4 Jul 2023
  • 277 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unstable doses of concomitant Crohn's disease therapy

Other illness

  • Complications of Crohn's disease that require surgical intervention or confound efficacy assessments

Other

  • Current diagnosis of ulcerative colitis or indeterminate colitis

Who the study is looking for

  • Diagnosis of Crohn's disease (CD) of at least 3 months in duration
  • Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (277)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health (Monash Medical Centre)
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ClaytonAustraliaUnknown status
Coral Sea Clinical Research Institute
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North MackayAustraliaUnknown status
OLV Ziekenhuis Aalst
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AalstBelgiumUnknown status
CHU Saint-Pierre
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BrusselsBelgiumUnknown status
Hôpital Erasme
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
Algemeen Ziekenhuis Delta
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RoeselareBelgiumUnknown status
Universidade Estadual Paulista "Julio De Mesquita Filho"
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BotucatuBrazilUnknown status
CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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BrasíliaBrazilUnknown status
Chronos Clinica Medica Ltda
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BrasíliaBrazilUnknown status
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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CampinasBrazilUnknown status
CDC - Centro Digestivo de Curitiba
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CuritibaBrazilUnknown status
Universidade Federal Do Ceara
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FortalezaBrazilUnknown status
Centro de Estudos Clínicos do Interior Paulista - CECIP
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JaúBrazilUnknown status
Cliged
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MacaéBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Instituto Mederi de Pesquisa e Saude
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Passo FundoBrazilUnknown status
Associacao Hospitalar Moinhos de Vento
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Porto AlegreBrazilUnknown status
Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
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Porto AlegreBrazilUnknown status
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Porto AlegreBrazilUnknown status
Hospital das Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital das Clinicas - Universidade Federal de Pernambuco
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RecifeBrazilUnknown status
SER - Servicos Especializados em Reumatologia da Bahia
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SalvadorBrazilUnknown status
Universidade Federal da Bahia - Hospital Professor Edgard Santos
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SalvadorBrazilUnknown status
Pesquisare Saude
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Santo AndréBrazilUnknown status
Irmandade da Santa Casa da Misericórdia de Santos
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SantosBrazilUnknown status
CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São Bernardo do CampoBrazilUnknown status
Kaiser Hospta
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São José do Rio PretoBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
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São José do Rio PretoBrazilUnknown status
Hepatogastro
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São PauloBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino (IDOR)
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São PauloBrazilUnknown status
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São PauloBrazilUnknown status
BR Trials - Ensaios Clínicos e Consultoria Ltda.
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São PauloBrazilUnknown status
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
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TeresinaBrazilUnknown status
Integral Centro de Pesquisas Clinicas
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VotuporangaBrazilUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
North Bay Dermatology Centre
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North BayCanadaUnknown status
The Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Changzhou No 2 Peoples Hospital
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ChangzhouChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing medical university
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ChongqingChinaUnknown status
The First People's Hospital of Foshan
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FoshanChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
First Affiliated Hospital Of Gannan Medical University
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GanzhouChinaUnknown status
Guangzhou First Municipal People's Hospital
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GuangzhouChinaUnknown status
Guangzhou Medical University
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GuangzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Nanjing 1st Hospital
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NanjingChinaUnknown status
The First Hospital of Quanzhou
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QuanzhouChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
The First Affiliated Hospital of Suzhou University
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SuzhouChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
Yangzhou First People's Hospital
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YangzhouChinaUnknown status
Zhuzhou Central Hospital
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ZhuzhouChinaUnknown status
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaActive, not recruiting
Oblastni nemocnice Kladno a.s.
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KladnoCzechiaActive, not recruiting
Nemocnice Slany
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SlanýCzechiaActive, not recruiting
CED-Studienzentrum Karlshorst
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Berlin-KarlshorstGermanyActive, not recruiting
MVZ Dachau
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DachauGermanyActive, not recruiting
Sydvestjysk Sygehus
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EsbjergDenmarkUnknown status
Nordsjaellands Hospital, Hillerod
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HilleroedDenmarkUnknown status
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
Semmelweis University
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Budapest VIIIHungaryActive, not recruiting
Haemek Medical Center
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AfulaIsraelUnknown status
Soroka University Medical Center
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BeershebaIsraelUnknown status
The Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Kaplan Medical Center
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RehovotIsraelUnknown status
Assaf Harofeh Medical Center
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TzrifinIsraelUnknown status
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Università Campus Bio-Medico di Roma
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RomeItalyCompleted
Khalidi Hospital and Medical Center
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AmmanJordanUnknown status
Abdali Hospital
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AmmanJordanUnknown status
Istiklal Hospital
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AmmanJordanUnknown status
The Speciality Hospital (TSH) / Advanced Clinical Center
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AmmanJordanUnknown status
Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
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IrbidJordanUnknown status
Irbid Specialty Hospital
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IrbidJordanUnknown status
Juntendo University Hospital
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Bunkyō CityJapanUnknown status
Ginza central clinic
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ChūōkuJapanUnknown status
Fukui Prefectural Hospital
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Fukui-kenJapanUnknown status
Japanese Red Cross Fukuoka Hospital
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FukuokaJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
National Hospital Organization Fukuyama Medical Center
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FukuyamaJapanUnknown status
Gamagori City Hospital
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GamagōriJapanUnknown status
Gunma University Hospital
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GunmaJapanUnknown status
Hachinohe City Hospital
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HachinoheJapanUnknown status
Matsuda Hospital
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HamamatsuJapanUnknown status
Hamamatsu University Hospital
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HamamatsuJapanUnknown status
National Hospital Organization Mito Medical Center
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Higashi-IbarakiJapanUnknown status
Kure Kyosai Hospital
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HiroshimaJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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Iizuka-shiJapanUnknown status
Kagoshima University Hospital
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KagoshimaJapanUnknown status
Kagoshima IBD Gastroenterology Clinic
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KagoshimaJapanUnknown status
Tsujinaka Hospital Kashiwanoha
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KashiwaJapanUnknown status
Kyushu Rosai Hospital
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KitakyushuJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
Yamanashi Prefectural Central Hospital
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KofuJapanUnknown status
Dokkyo Medical University Saitama Medical Center
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KoshigayaJapanUnknown status
Hidaka Coloproctologic Clinic
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KurumeJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Japanese Red Cross Kyoto Daini Hospital
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KyotoJapanUnknown status
Iwate Medical University Hospital
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MoriokaJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
Yokoyama IBD Clinic
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NagoyaJapanUnknown status
University of the Ryukyus Hospital
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Nakagami GunJapanUnknown status
Niigata University Medical and Dental Hospital
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NiigataJapanUnknown status
Nishinomiya Municipal Central Hospital
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NishinomiyaJapanUnknown status
Oita Red Cross Hospital
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ŌitaJapanUnknown status
Osaka General Medical Center
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OsakaJapanUnknown status
National Hospital Organization Osaka National Hospital
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OsakaJapanUnknown status
Kinshukai Infusion Clinic
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OsakaJapanUnknown status
Japanese Red Cross Osaka Hospital
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OsakaJapanUnknown status
Shiga University of Medical Science Hospital
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ŌtsuJapanUnknown status
Sapporo Higashi Tokushukai Hospital
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SapporoJapanUnknown status
Takagi Clinic
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SendaiJapanUnknown status
National Hospital Organization Shizuoka Medical Center
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Sunto-gunJapanUnknown status
Tokyo Medical University Hospital
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TokyoJapanUnknown status
Toyota Kosei Hospital
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ToyotaJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
DongA Medical Center
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BusanSouth KoreaUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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BusanSouth KoreaUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Yeungnam University Medical Center
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DaeguSouth KoreaUnknown status
The Catholic University of Korea Seoul St.Mary's Hospital
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DaejeonSouth KoreaUnknown status
Kyung Hee University Hospital
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Dongdaemun-guSouth KoreaUnknown status
Dongguk University Ilsan Hospital
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hospital
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GwangjuSouth KoreaUnknown status
CHA Bundang Medical Center, CHA University
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Gyeonggi-doSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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Gyeonggi-doSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Yonsei University College of Medicine
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Wonju Christian Hospital
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WŏnjuSouth KoreaUnknown status
Ewha Womans University Mokdong Hospital
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Yangch’ŏn-guSouth KoreaUnknown status
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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KaunasLithuaniaActive, not recruiting
Hospital Sultanah Aminah
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Johor BharuMalaysiaUnknown status
Hospital University Sains Malaysia
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Kota BharuMalaysiaUnknown status
Hospital Raja Permaisuri Bainun
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Kota KinabaluMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Tengku Ampuan Afzan
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KuantanMalaysiaUnknown status
Onze Lieve Vrouwe Gasthuis
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AmsterdamNetherlandsUnknown status
Sint Franciscus Gasthuis
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RotterdamNetherlandsUnknown status
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Dunedin Hospital
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DunedinNew ZealandUnknown status
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
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BydgoszczPolandActive, not recruiting
Centrum Medyczne Lukamed Sp z o o
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ChojnicePolandActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandActive, not recruiting
MZ Badania Slowik Zymla Sp.j.
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KnurówPolandActive, not recruiting
Centrum Medyczne Med-Gastr Sp. z o.o.
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LodzPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandActive, not recruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
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PoznanPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandActive, not recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandActive, not recruiting
Sonomed Sp. z o.o.
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SzczecinPolandActive, not recruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
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TychyPolandActive, not recruiting
Vivamed Sp. z o.o.
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WarsawPolandActive, not recruiting
Medical Network Sp z o o
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WarsawPolandActive, not recruiting
Bodyclinic sp. z o.o. sp.k.
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WarsawPolandActive, not recruiting
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
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WloclawekPolandActive, not recruiting
Vistamed & Vertigo Sp Z O O
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WroclawPolandActive, not recruiting
Melita Medical Sp. z o.o.
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WroclawPolandActive, not recruiting
Pro Life Medica Sp. z o.o.
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ZamośćPolandActive, not recruiting
ENDOMED, s.r.o.
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KošiceSlovakiaActive, not recruiting
GASTRO I., s.r.o.
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PrešovSlovakiaActive, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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KaoshiungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Medical University
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TaipeiTaiwanUnknown status
National Taiwan University Hospital, Division of Infectious Diseases
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Clinnova Research
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AnaheimUnited StatesUnknown status
Atlanta Gastroenterology Specialists, PC
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AtlantaUnited StatesUnknown status
Agile Clinical Research Trials, LLC
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AtlantaUnited StatesUnknown status
Institute for Digestive Health and Liver Disease
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BaltimoreUnited StatesUnknown status
USF Asthma, Allergy, Immunology Clinical Research Unit
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BoiseUnited StatesUnknown status
SUNY Downstate Medical Center
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BrooklynUnited StatesUnknown status
Burke Internal Medicine and Research
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BurkeUnited StatesUnknown status
Advanced Gastro P.C
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ChandlerUnited StatesUnknown status
OnSite Clinical Solutions
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CharlotteUnited StatesUnknown status
Carolinas Medical Center
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CharlotteUnited StatesUnknown status
Digestive Health Specialists PC
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ChelmsfordUnited StatesUnknown status
Gastroenterology Associates of Tidewater
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ChesapeakeUnited StatesUnknown status
Clinical Research Institute of Michigan, LLC
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ChesterfieldUnited StatesUnknown status
Gastroenterology Associates of SW Florida
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ClearwaterUnited StatesUnknown status
Pioneer Research Solutions Inc.
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Coconut CreekUnited StatesUnknown status
Central Ohio Endoscopy Center LLC
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ColumbusUnited StatesUnknown status
Tri-State Gastroenterology Assoc
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Crestview HillsUnited StatesUnknown status
Western Connecticut Health Network/Danbury Hospital
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DanburyUnited StatesUnknown status
Dayton Gastroenterology, Inc
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DaytonUnited StatesUnknown status
Omega Research Consultants
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DeBaryUnited StatesUnknown status
Atlanta Center For Gastroenterology
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DecaturUnited StatesUnknown status
Digestive Health Specialists of the Southeast
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DothanUnited StatesUnknown status
Woodholme Gastroenterology Associates
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Glen BurnieUnited StatesUnknown status
Amel Med LLC Research
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Grand JunctionUnited StatesUnknown status
Gastroenterology Associates P.A.
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GreenvilleUnited StatesUnknown status
Carolina Research
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GreenvilleUnited StatesUnknown status
Harmony Medical Research Institute, Inc.
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HialeahUnited StatesUnknown status
Grand Teton Research Group, PLLC
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Idaho FallsUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Smart Medical Research
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Jackson HeightsUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Central Florida Gastro Research
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KissimmeeUnited StatesUnknown status
Om Research LLC
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LancasterUnited StatesUnknown status
Om Research, LLC 1
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LancasterUnited StatesUnknown status
BVL Clinical Research
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LeawoodUnited StatesUnknown status
Moore Clinical Trials, LLC
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Little RockUnited StatesUnknown status
Central Arkansas Veterans Healthcare System
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Little RockUnited StatesUnknown status
Detroit Clinical Research Center
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LivoniaUnited StatesUnknown status
United Gastroenterologists
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Los AlamitosUnited StatesUnknown status
Paul Wallace MD
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Los AngelesUnited StatesUnknown status
West Texas Clinical Research
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LubbockUnited StatesUnknown status
Gastroenterolgy Associates of Central GA
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MaconUnited StatesUnknown status
Tandem Clinical Research
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MarreroUnited StatesUnknown status
Great Lakes Gastroenterology
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MentorUnited StatesUnknown status
Community Research Foundation, Inc.
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MiamiUnited StatesUnknown status
Crystal Run Healthcare LLP
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MiddletownUnited StatesUnknown status
Carolina Health Specialists
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Myrtle BeachUnited StatesUnknown status
Gastroenterology Group of Naples
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NaplesUnited StatesUnknown status
New York Gastroenterology Associates
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New YorkUnited StatesUnknown status
DiGiovanna Institute for Medical Education & Research
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North MassapequaUnited StatesUnknown status
Lemah Creek Clinical Research
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Oakbrook TerraceUnited StatesUnknown status
Integris Baptist Office
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Oklahoma CityUnited StatesUnknown status
Central Sooner Research
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Oklahoma CityUnited StatesUnknown status
Oklahoma University Health Science Center
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Oklahoma CityUnited StatesUnknown status
Center for Digestive Health
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OrlandoUnited StatesUnknown status
Central Florida Internists
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OrlandoUnited StatesUnknown status
Digestive System Healthcare
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PasadenaUnited StatesUnknown status
The Oregon Clinic
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PortlandUnited StatesUnknown status
A1 Clinical Network
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QueensUnited StatesUnknown status
Victoria Gastroenterology
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RichmondUnited StatesUnknown status
Gastroenterology Consultants
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RoswellUnited StatesUnknown status
Care Access Research- Salt Lake City
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Salt Lake CityUnited StatesUnknown status
Gastroenterology Clinic Of San Antonio P A
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San AntonioUnited StatesUnknown status
Wellness Clinical Research
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San AntonioUnited StatesUnknown status
Clinical Applications Laboratories, Inc.
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San DiegoUnited StatesUnknown status
Northshore Gastroenterology Research, LLC
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San DiegoUnited StatesUnknown status
Santa Maria Gastroenterology
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Santa MariaUnited StatesUnknown status
Reliance Research
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ScottsdaleUnited StatesUnknown status
Frontier Clinical Research
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SmithfieldUnited StatesUnknown status
FC Research, LLC
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South DartmouthUnited StatesUnknown status
Texas Digestive Disease Consultants
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SouthlakeUnited StatesUnknown status
Synergy Clinical Research
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St. PetersburgUnited StatesUnknown status
Cotton O'Neil Digestive Health Center
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TopekaUnited StatesUnknown status
Essential Medical Research
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TulsaUnited StatesUnknown status
Digestive Health Specialists of Tyler
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TylerUnited StatesUnknown status
Clinical Research of California
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Walnut CreekUnited StatesUnknown status
Gastroenterology Associates of the Piedmont, P.A.
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Winston-SalemUnited StatesUnknown status
Hacettepe University Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ankara Numune Egitim ve Arastirma Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Gazi University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
University hospital Clinical centre Banja Luka
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Banja LukaBosnia and HerzegovinaUnknown status
Acibadem Fulya Hospital
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IstanbulTurkey (Türkiye)Unknown status
Ege Universitesi Tip Fakultesi
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IzmirTurkey (Türkiye)Unknown status
Mersin University Medical Faculty
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MersinTurkey (Türkiye)Unknown status
Ondokuz Mayis University
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SamsunTurkey (Türkiye)Unknown status
Clinical center University of Sarajevo
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SarajevoBosnia and HerzegovinaUnknown status
Polyclinic Dr. Al-Tawil
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SarajevoBosnia and HerzegovinaUnknown status
General Hospital Tesanj
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TešanjBosnia and HerzegovinaUnknown status
Plava poliklinika Tuzla
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TuzlaBosnia and HerzegovinaUnknown status
Cantonal Hospital Zenica
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ZenicaBosnia and HerzegovinaUnknown status
Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
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ZonguldakTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.