Last updated on September 2017

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease


Brief description of study

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

Clinical Study Identifier: NCT02596893

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Asheville, NC United States
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CHU Dijon - Hopital Bocage Central
Dijon, France
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CHU de Grenoble Hopital Nord
Grenoble cedex 9, France
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Groupement Hospitalier Sud Hopital Bicetre
Le Kremlin Bicetre cedex, France
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Hopital Claude Huriez CHRU Lille
Lille cedex, France
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Hopital Nord
Marseille cedex 20, France
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CHU Nantes Hotel Dieu
Nantes Cedex 1, France
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CHU Nice Hopital de lArchet 2
Nice Cedex 3, France
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Groupe Hospitalier Sud Hopital Haut Leveque USN
Pessac, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex, France
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CHU Reims Hopital Robert Debre
Reims, France
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CHU Rennes Hopital Pontchaillou
Rennes cedex 09, France
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CHU de Rouen Hopital Charles Nicolle
Rouen Cedex, France
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CHU Saint Etienne Hopital Nord
Saint Etienne, France
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CHU Strasbourg Hopital Hautepierre
Strasbourg Cedex, France
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CHU de Toulouse Hopital Rangueil
Toulouse Cedex 09, France
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Hopital de Brabois Adultes
Vandoeuvre les Nancy, France
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Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
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Charite Campus Virchow Klinikum
Berlin, Germany
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DRK Kliniken Berlin Westend
Berlin, Germany
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Krankenhaus Waldfriede e V
Berlin, Germany
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Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, Germany
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Staedisches Klinikum Brandenburg
Brandenburg an der Havel, Germany
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Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
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Zentrum fuer HIV und Hepatogastroenterologie GmbH
Duesseldorf, Germany
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Universitaetsklinikum Erlangen
Erlangen, Germany
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Katholische Kliniken Ruhrhalbinsel GmbH
Essen, Germany
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Agaplesion Markus Krankenhaus
Frankfurt, Germany
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Crohn Colitis Centrum Rhein Main
Frankfurt, Germany
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Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg, Germany
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Universitaetsklinikum Halle Saale
Halle, Germany
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Asklepios Klinik Hamburg
Hamburg, Germany
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Medizinische Hochschule Hannover
Hannover, Germany
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Universitaetsklinikum Heidelberg
Heidelberg, Germany
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Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
Heidelberg, Germany
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Universitaetsklinikum Jena
Jena, Germany
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Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, Germany
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Universitaetsklinikum Koeln
Koeln, Germany
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Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen
Leipzig, Germany
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Medizinisches Zentrum Klinikum Lueneburg
Lueneburg, Germany
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Universitaetsklinikum Magdeburg A oeR
Magdeburg, Germany
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Klinikum Mannheim GmbH Universitaetsklinikum
Mannheim, Germany
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Gastroenterologische Praxis Minden
Minden, Germany
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Universitaetsklinikum Muenster
Muenster, Germany
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Gastro Campus Research
Muenster, Germany
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Klinikum der Universitaet Muenchen
München, Germany
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Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
Niedersachsen, Germany
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Universitaetsklinikum Regensburg
Regensburg, Germany
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Universitaetsklinikum Ulm
Ulm, Germany
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University General Hospital of Alexandroupolis
Alexandroupolis, Greece
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General Hospital of Athens Evangelismos
Athens, Greece
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General Hospital of Nikaea Piraeus Ag. Panteleimon
Athens, Greece
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University General Hospital of Heraklion
Heraklion, Greece
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General Hospital of Heraklion Benizeleio Pananeio
Heraklion, Greece
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University General Hospital of Ioannina
Ioannina, Greece
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University General Hospital of Patras
Rio Patras, Greece
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Anticancer Hospital of Thessaloniki THEAGENIO
Thessaloniki, Greece
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General Hospital of Thessaloniki Hippokration
Thessaloniki, Greece
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DRC Gyogyszervizsgalo Kozpont Kft
Balatonfured, Hungary
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Clinexpert Egeszsegugyi Szolg es Ker Kft
Budapest, Hungary
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Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary
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Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
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Semmelweis Egyetem AOK
Budapest, Hungary
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Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary
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Pannonia Maganorvosi Centrum
Budapest, Hungary
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Endomedix Diagnosztikai Kozpont
Budapest, Hungary
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Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
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Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
Dunaujvaros, Hungary
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Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, Hungary
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Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary
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Associate Director Clinical Trial Disclosure

Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary
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Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar, Hungary
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SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza, Hungary
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Mazso-Pharma Kutatas-fejlesztesi Kft
Szeged, Hungary
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Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar, Hungary
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Clinfan Szolgaltato Kft
Szekszard, Hungary
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Associate Director Clinical Trial Disclosure

Soroka University Medical Center
Beer Sheva, Israel
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Rambam Health Care Campus
Haifa, Israel
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Shaare Zedek Medical Center
Jerusalem, Israel
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Hadassah University Hospital
Jerusalem, Israel
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Rabin Medical Center
Petah Tikva, Israel
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Chaim Sheba Medical Center
Ramat Gan, Israel
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Kaplan Medical Center
Rechovot, Israel
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Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, Israel
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The Baruch Padeh MC, Poriya
Tiberias, Israel
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Assaf Harofeh Medical Center
Zerifin, Israel
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Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
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Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
Bologna, Italy
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Azienda Ospedaliera Universitaria Careggi
Firenze, Italy
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Azienda Ospedaliera Universitaria Policlinico G Martino
Messina, Italy
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Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milano, Italy
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Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
Milano, Italy
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Seconda Universita Degli Studi Di Napoli
Naples, Italy
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Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
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Azienda Ospedaliera Di Padova
Padova, Italy
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Azienda Ospedaliera Vincenzo Cervello
Palermo, Italy
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Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
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Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
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Universita Campus Bio-Medico di Roma
Roma, Italy
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Complesso Integrato Columbus
Roma, Italy
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Policlinico Universitario Agostino Gemelli
Roma, Italy
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Azienda Ospedaliera San Camillo Forlanini
Rome, Italy
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Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
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Istituto Clinico Humanitas
Rozzano (MI), Italy
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Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
Salerno, Italy
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IRCCS Policlinico San Donato
San Donato Milanese, Italy
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IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo FG, Italy
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Ospedale Mauriziano Umberto I
Torino, Italy
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Associate Director Clinical Trial Disclosure

Dong-A University Hospital
Busan, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Pusan National University Hospital
Busan, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Yeungnam University Medical Center
Daegu, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Hanyang Univerisy Guri Hospital
Guri-si, Korea, Republic of
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Associate Director Clinical Trial Disclosure

CHA Bundang Medical Center CHA University
Seongnam-si,, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Kyung Hee University Hospital
Seoul, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Kangbuk Samsung Hospital
Seoul, Korea, Republic of
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Asan Medical Center
Seoul, Korea, Republic of
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Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Samsung Medical Center
Seoul, Korea, Republic of
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Korea University Anam Hospital
Seoul, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
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The Catholic University of Korea, St.Vicent's Hospital
Suwon-si, Korea, Republic of
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Associate Director Clinical Trial Disclosure

Digestive Diseases Center Gastro
Riga, Latvia
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Riga East Clinical University Hospital clinic Gailezers
Riga, Latvia
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Pauls Stradins Clinical University Hospital
Riga, Latvia
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Hospital Sultanah Bahiyah
Alor Setar, Malaysia
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Hospital Raja Perempuan Zainab II
Kota Bahru, Malaysia
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University Malaya Medical Centre
Kuala Lumpur, Malaysia
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Hospital Universiti Sains Malaysia
Kelantan, Malaysia
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VU Medisch Centrum
Amsterdam, Netherlands
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Academisch Medisch Centrum
Amsterdam, Netherlands
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Universitair Medisch Centrum Groningen
Groningen, Netherlands
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Leiden Universitair Medisch Centrum
Leiden, Netherlands
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Medisch Centrum Haaglanden,Antoniushoeve
Leidschendam, Netherlands
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Maasstad Ziekenhuis
Rotterdam, Netherlands
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Associate Director Clinical Trial Disclosure

Zuyderland Medisch Centrum
Sittard-Geleen, Netherlands
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St. Elisabeth Ziekenhuis
Tilburg, Netherlands
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University Medical Center Utrecht
Utrecht, Netherlands
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Waikato Hospital
Hamilton, New Zealand
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Sykehuset Ostfold Fredrikstad
Fredrikstad, Norway
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Akershus universitetssykehus HF
Lørenskog, Norway
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Oslo Universitetssykehus HF Ulleval
Oslo, Norway
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Oslo Universitetssykehus Rikshospitalet
Oslo, Norway
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Stavanger Unviversitetssjukehus Helse Stavanger HF
Stavanger, Norway
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SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, Poland
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Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz, Poland
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Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
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Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
Kielce, Poland
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Indywidualna Praktyka Lekarska Maciej Zymla
Knurow, Poland
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Centrum Medyczne Plejady
Krakow, Poland
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SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
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SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
Lodz, Poland
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Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, Poland
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Associate Director Clinical Trial Disclosure

Centrum Medyczne Medyk
Rzeszow, Poland
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LexMedica Osrodek Badan Klinicznych
Wroclaw, Poland
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Associate Director Clinical Trial Disclosure

Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, Portugal
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Hospital da Senhora da Oliveira Guimaraes
Guimaraes, Portugal
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Centro Hospitalar de Sao Joao, EPE
Porto, Portugal
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Associate Director Clinical Trial Disclosure

Centro Hospitalar do Alto Minho - Unidade Local de Sa de do Alto Minho, EPE
Viana do Castelo, Portugal
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Tvm Med Serv Srl
Cluj Napoca, Romania
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Spitalul Clinic Judetean de Urgente Sf. Spiridon
Iasi, Romania
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CMI Dr. Tirnaveanu Amelita
Oradea, Romania
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Associate Director Clinical Trial Disclosure

Centrul de Gastroenterologie Dr. Goldis
Timisoara, Romania
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Associate Director Clinical Trial Disclosure

Irkutsk State Medical Academy of Continuing Education
Irkutsk, Russian Federation
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TSBIH Territorial Clinical Hospital
Krasnoyarsk, Russian Federation
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Medical Center Stolitsa-Medikl
Moscow, Russian Federation
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SBHI of NN region RCH of NN n.a. N.A.Semashko
Nizhny Novgorod, Russian Federation
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SBEIHPE Novosibirsk State Medical University
Novosibirsk, Russian Federation
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RSHI State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation
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Associate Director Clinical Trial Disclosure

FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
Novosibirsk, Russian Federation
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BHI of Omsk region Clinical Oncology Dispensary
Omsk, Russian Federation
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Associate Director Clinical Trial Disclosure

SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
Omsk, Russian Federation
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Associate Director Clinical Trial Disclosure

SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral
Perm, Russian Federation
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Associate Director Clinical Trial Disclosure

Evromedservis
Pushkin, Russian Federation
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Associate Director Clinical Trial Disclosure

SEIHPE Rostov State Medical University of MoH of RF
Rostov-on-Don, Russian Federation
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Associate Director Clinical Trial Disclosure

City Mariinskaya Hospital
Saint-Petersburg, Russian Federation
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Associate Director Clinical Trial Disclosure

SPb SBIH City Hospital # 26
Saint-Petersburg, Russian Federation
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Associate Director Clinical Trial Disclosure

Private Educational Institution of Higher Education Medical university REAVIZ
Samara, Russian Federation
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Associate Director Clinical Trial Disclosure

NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
Samara, Russian Federation
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Associate Director Clinical Trial Disclosure

SHI Regional Clinical Hospital
Saratov, Russian Federation
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Associate Director Clinical Trial Disclosure

SPb SBIH City Hospital of Saint Martyr Elizaveta
St. Petersburg, Russian Federation
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Associate Director Clinical Trial Disclosure

SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno
Tosno, Russian Federation
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SBHI of Yaroslavl Region Clinical Hospital 8
Yaroslavl, Russian Federation
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Associate Director Clinical Trial Disclosure

Clinical Center of Serbia
Belgrade, Serbia
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Associate Director Clinical Trial Disclosure

Clinical Center Zvezdara
Belgrade, Serbia
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Associate Director Clinical Trial Disclosure

Military Medical Academy
Belgrade, Serbia
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Associate Director Clinical Trial Disclosure

Clinical Center Bezanijska Kosa
Belgrade, Serbia
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Associate Director Clinical Trial Disclosure

Clinical Center Zemun
Belgrade, Serbia
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Associate Director Clinical Trial Disclosure

Clinical Center Kragujevac
Kragujevac, Serbia
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Associate Director Clinical Trial Disclosure

Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banska Bystrica, Slovakia
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Associate Director Clinical Trial Disclosure

Univerzitna nemocnica Bratislava Nemocnica Ruzinov
Bratislava, Slovakia
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Gastroentero-Hepatologicke centrum THALION
Bratislava, Slovakia
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Associate Director Clinical Trial Disclosure

Nemocnica A.Lena Humenne n o
Humenne, Slovakia
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Associate Director Clinical Trial Disclosure

Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
Malacky, Slovakia
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Fakultna nemocnica Nitra
Nitra, Slovakia
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Associate Director Clinical Trial Disclosure

KM Management, spol. s r.o.
Nitra, Slovakia
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Associate Director Clinical Trial Disclosure

Nemocnica s poliklinikou sv Barbory Roznava a s
Roznava, Slovakia
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Associate Director Clinical Trial Disclosure

Fakultna nemocnica s poliklinikou Zilina
Zilina, Slovakia
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Associate Director Clinical Trial Disclosure

Hospital Universitari Germans Trias i Pujol
Badalona, Spain
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Associate Director Clinical Trial Disclosure

Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario Reina Sofia
Cordoba, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario de la Princesa
Madrid, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario Ramon y Cajal
Madrid, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
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Corporacion Sanitaria Parc Tauli
Sabadell, Spain
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Hospital Universitario Infanta Sofia
San Sebastian de los Reyes, Spain
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Hospital Universitario Virgen Del Rocio
Sevilla, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario Virgen Macarena
Sevilla, Spain
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Associate Director Clinical Trial Disclosure

Hospital Universitario Miguel Servet
Zaragoza, Spain
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Associate Director Clinical Trial Disclosure

Danderyds Sjukhus AB
Stockholm, Sweden
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Associate Director Clinical Trial Disclosure

Universitaetsspital Basel
Basel, Switzerland
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Associate Director Clinical Trial Disclosure

Inselspital - Universitaetsspital Bern
Bern, Switzerland
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Associate Director Clinical Trial Disclosure

Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
Bern, Switzerland
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Kantonsspital Bruderholz
Bruderholz, Switzerland
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Associate Director Clinical Trial Disclosure

Kantonsspital St.Gallen
St. Gallen, Switzerland
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Associate Director Clinical Trial Disclosure

Universitaetsspital Zuerich
Zuerich, Switzerland
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Associate Director Clinical Trial Disclosure

Ankara University Medical Faculty
Ankara, Turkey
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Associate Director Clinical Trial Disclosure

Hacettepe University Medical Faculty
Ankara, Turkey
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Associate Director Clinical Trial Disclosure

Turkiye Yuksek Ihtisas Hospital
Ankara, Turkey
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Associate Director Clinical Trial Disclosure

Gazi University Medical Faculty
Ankara, Turkey
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Associate Director Clinical Trial Disclosure

Firat University Medical Faculty
Elazig, Turkey
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Associate Director Clinical Trial Disclosure

Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, Turkey
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Associate Director Clinical Trial Disclosure

Yeditepe University Medical School Hospital
Istanbul, Turkey
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Associate Director Clinical Trial Disclosure

Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul, Turkey
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Associate Director Clinical Trial Disclosure

Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey
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Associate Director Clinical Trial Disclosure

Acibadem Fulya Hospital
Istanbul, Turkey
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Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey
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Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul, Turkey
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Marmara University Pendik Training and Research Hospital
Istanbul, Turkey
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Ege University Medical Faculty
Izmir, Turkey
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Mersin University Medical Faculty
Mersin, Turkey
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Kocaeli Derince Training and Research Hospital
Umuttepe Kocaeli, Turkey
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RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
Chernivtsi, Ukraine
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CI of PH Kharkiv CCH #2
Kharkiv, Ukraine
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GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, Ukraine
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Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
Kirovohrad, Ukraine
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Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
Kyiv, Ukraine
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Kyiv City Clinical Hospital #1
Kyiv, Ukraine
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SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
Kyiv, Ukraine
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Lviv Regional Clinical Hospital D Halytskyi Lviv NMU
Lviv, Ukraine
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Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
Lviv, Ukraine
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CI Odesa Regional Clinical Hospital
Odessa, Ukraine
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Communal Institution City Policlinic #20 Cabinet of Gastroenterology
Odessa, Ukraine
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M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
Poltava, Ukraine
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CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
Sumy, Ukraine
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Ternopil City Communal Emergency Medical Care Hospital
Ternopil, Ukraine
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M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, Ukraine
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SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, Ukraine
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SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhia, Ukraine
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CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporozhje, Ukraine
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Queen Elizabeth Hospital
Birmingham, United Kingdom
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Bristol Royal Infirmary
Bristol, United Kingdom
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Royal Devon and Exeter Hospital Wonford
Exeter, United Kingdom
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Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
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Queen Elizabeth University Hospital
Glasgow, United Kingdom
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Hull Royal Infirmary
Hull, United Kingdom
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Royal London Hospital
London, United Kingdom
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St Marys Hospital
London, United Kingdom
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Manchester Royal Infirmary
Manchester, United Kingdom
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University Hospital of South Manchester NHS Foundation Trust
Manchester, United Kingdom
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Nottingham University Hospitals Queens Medical Centre
Nottingham, United Kingdom
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John Radcliffe Hospital
Oxford, United Kingdom
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Borders General Hospital
Roxburghshire, United Kingdom
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Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
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Southampton General Hospital
Southhampton, United Kingdom
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