NCT03766581
Active, not recruiting
December 6, 2018
April 5, 2022
Brief summary:
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel Specified Dose on Specified Days |
Drug: BMS-986177 Oral administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Placebo Comparator: BMS-986177 Placebo Specified Dose on Specified Days |
Other: Placebo Oral Administration Drug: Clopidogrel Oral administration Drug: Aspirin Oral administration |
Inclusion Criteria: Male and Female ≥40 years of age Acute Ischemic Stroke or Transient Ischemic Attack Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area Exclusion Criteria: Predicted inability to swallow study medication Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke Other protocol defined inclusion/exclusion criteria could apply
United States, Alabama
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham
United States, California
Glendale Adventist Medical Center
Glendale
United States, California
Long Beach Memorial Medical Center
Long Beach
United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles
United States, California
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles
United States, California
UC Davis Health
Sacramento
United States, California
Stanford Stroke Center
Stanford
United States, California
Harbor UCLA Medical Center
Torrance
United States, Delaware
Christiana Care Health System
Newark
United States, Florida
UF Health Neurovascular Hospital
Gainesville
United States, Florida
Sarasota Memorial Hospital
Sarasota
United States, Florida
University of South Florida
Tampa
United States, Georgia
Augusta University
Augusta
United States, Hawaii
The Queens Medical Center
Honolulu
United States, Illinois
University of Illinois at Chicago
Chicago
United States, Illinois
University of Illinois Hospital & Health Sciences System
Chicago
United States, Illinois
Alexian Brothers Health System
Elk Grove Village
United States, Illinois
Mercyhealth Javon Bea Hospital- Riverside
Rockford
United States, Kentucky
University of Louisville Hospital
Louisville
United States, Louisiana
Ochsner Clinic Foundation
New Orleans
United States, Maryland
Sinai Hospital of Baltimore
Baltimore
United States, Massachusetts
Local Institution
Boston
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston
United States, Michigan
Local Institution
Detroit
United States, Michigan
Henry Ford Hospital
Detroit
United States, Michigan
Local Institution
Detroit
United States, Michigan
Ascension Providence Hospital - Novi Campus
Farmington Hills
United States, Minnesota
Local Institution
Minneapolis
United States, Missouri
Local Institution
Kansas City
United States, Missouri
Local Institution
Saint Louis
United States, Missouri
Barnes Jewish Hospital
Saint Louis
United States, Missouri
Washington University School Of Medicine
Saint Louis
United States, Montana
Advanced Neurology Specialists PLLC
Great Falls
United States, New Jersey
Cooper University Hospital
Camden
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick
United States, New York
SUNY Downstate Health Science University
Brooklyn
United States, New York
Local Institution
Buffalo
United States, New York
Local Institution
New York
United States, New York
Columbia University Medical Center
New York
United States, North Carolina
Duke University Medical Center
Butner
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
United States, North Carolina
Guilford Neurologic Research, PA
Greensboro
United States, North Carolina
Local Institution
Winston-Salem
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland
United States, Ohio
The Cleveland Clinic Foundation
Cleveland
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus
United States, Oklahoma
INTEGRIS Baptist Medical Center
Oklahoma City
United States, Oregon
Oregon Health and Science University
Portland
United States, Pennsylvania
Abington Memorial Hospital
Abington
United States, Pennsylvania
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Allentown
United States, Pennsylvania
Local Institution
Camp Hill
United States, Pennsylvania
UPMC Hamot
Erie
United States, Pennsylvania
Hospital of The University of Pennsylvania
Philadelphia
United States, Pennsylvania
Temple University Hospital
Philadelphia
United States, Pennsylvania
WellSpan York Hospital
York
United States, South Carolina
Prisma Health-Midlands
Columbia
United States, Tennessee
Vanderbilt University Medical Center
Nashville
United States, Texas
Dell Seton Medical School at The University of Texas - Stroke Institute
Austin
United States, Texas
Neurology Consultants of Dallas, PA
Dallas
United States, Texas
Local Institution
Dallas
United States, Texas
University Medical center of El Paso
El Paso
United States, Texas
Methodist Neurological Institute
Houston
United States, Texas
University of Texas Health Science Center at Houston
Houston
United States, Texas
Baylor Scott and White Research Institute
Temple
United States, Virginia
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Richmond
United States, Wisconsin
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Milwaukee
Argentina, Buenos Aires
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Caba
Argentina, Buenos Aires
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Caba
Argentina, Buenos Aires
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Caba
Argentina, Buenos Aires
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Ciudad Autonoma de Buenos Aires
Argentina, Buenos Aires
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Lomas de Zamora
Argentina
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Buenos Aires
Argentina
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Buenos Aires
Argentina
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Buenos Aires
Argentina
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Santa Fe
Australia, New South Wales
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Randwick
Australia, New South Wales
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Sydney
Australia, Queensland
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Southport
Australia, South Australia
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Adelaide
Australia, Tasmania
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Launceston
Australia, Victoria
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Clayton
Australia, Victoria
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Heidelberg
Australia, Western Australia
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Murdoch
Austria
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Klagenfurt Am Woerthersee
Austria
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St. Pölten
Austria
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Vocklabruck
Austria
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Wien
Belgium, Namur
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Yvoir
Belgium
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Brasschaat
Belgium
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Bruges
Belgium
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Brussels
Belgium
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Brussels
Belgium
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Brussel
Belgium
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Bruxelles
Belgium
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Edegem
Belgium
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Gent
Belgium
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Kortrijk
Belgium
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Leuven
Belgium
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Liege
Brazil, Ceara
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Fortaleza
Brazil, Minas Gerais
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Uberaba
Brazil, Parana
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Curitiba
Brazil, Rio Grande Do Sul
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Porto Alegre
Brazil, Santa Catarina
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Joinville
Brazil, SAO Paulo
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Botucatu
Brazil, SAO Paulo
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Campinas
Brazil, SAO Paulo
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Ribeirao Preto
Brazil, SAO Paulo
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Santo Andre
Brazil, SAO Paulo
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São Paulo
Brazil, SAO Paulo
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São Paulo
Canada, Alberta
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Calgary
Canada, Alberta
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Edmonton
Canada, Alberta
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Lethbridge
Canada, British Columbia
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New Westminster
Canada, British Columbia
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Vancouver
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Hamilton
Canada, Ontario
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Kingston
Canada, Ontario
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London
Canada, Ontario
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Toronto
Canada, Ontario
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Toronto
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Chicoutimi
Canada, Quebec
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Greenfield Park
Canada, Quebec
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Montreal
Canada
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Quebec
Chile, Los Rios
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Valdivia
Chile, Valparaiso
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Vina del Mar
Chile
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Los Angeles
China, Beijing
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Beijing
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Guangzhou
China, Hainan
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Haikou
China, Heilongjiang
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Daqing
China, Henan
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Zhengzhou
China, Jiangsu
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Nantong
China, Jiangsu
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Yangzhou
China, Jilin
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Changchun
China, Liaoning
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Shenyang
China, Shandong
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Qingdao
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YanTai
China, Zhejiang
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Wenzhou
Czechia
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Brno
Czechia
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Ceske Budejovice
Czechia
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Jihlava
Czechia
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Olomouc
Czechia
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Ostrava
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Praha 2
Denmark
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Aalborg
Denmark
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Aarhus N
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Copenhagen
Denmark
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Glostrup
Denmark
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Herlev
Finland, Etelä-Suomen Lääni
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Helsinki
Finland
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Lappeenranta
Finland
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Turku
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Bordeaux
France
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Bourg-en-Bresse
France
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France
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Lille
France
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Limoges Cedex
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Marseille
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Montpellier Cedex 5
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Paris cedex 10
France
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Paris
France
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Paris
France
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France
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Rouen Cedex
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Toulouse Cedex 9
Germany
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Altenburg
Germany
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Berlin
Germany
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Germany
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Bielefeld
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Bonn
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Dresden
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Erlangen
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Essen
Germany
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Frankfurt Am Maim
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Frankfurt am Main
Germany
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Gießen
Germany
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Hamburg
Germany
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Hamburg
Germany
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Hamburg
Germany
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Hannover
Germany
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Heidelberg
Germany
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Leipzig
Germany
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Lübeck
Germany
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Magdeburg
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Minden
Germany
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Munster
Germany
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Osnabruck
Germany
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Regensburg
Germany
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Sande
Germany
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Siegen
Germany
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Sindelfingen
Germany
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Tubingen
Germany
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Ulm
Greece, Attiki
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Athina
Greece
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Athens
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Athens
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Athens
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Athens
Greece
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Greece
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Athens
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Crete
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Local Institution - 0333
Ioannina
Greece
Local Institution - 0365
Ioannina
Greece
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Ioannina
Greece
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Larissa,
Greece
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Larissa
Greece
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Larissa
Greece
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Neo Faliro
Greece
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Patras
Greece
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Pireaus
Greece
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Thessaloniki
Greece
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Greece
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Thessaloniki
Greece
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Greece
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Thessaloniki
Hong Kong
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Hong Kong
Hungary
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Budapest
Hungary
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Budapest
Hungary
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Budapest
Hungary
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Budapest
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Debrecen
Hungary
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Gyor
Hungary
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Kistarcsa
Hungary
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Kisvárda
Hungary
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Miskolc
Hungary
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Nyíregyháza
Hungary
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Pecs
Hungary
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Szeged
Hungary
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Zalaegerszeg
Israel
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Beer-Sheva
Israel
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Haifa
Israel
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Haifa
Israel
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Jerusalem
Israel
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Jerusalem
Israel
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Nahariya
Israel
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Petach Tikva
Israel
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Ramat-Gan
Israel
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Tel Aviv
Italy, Marche
Local Institution - 0151
Ancona
Italy
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Bologna
Italy
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Cagliari
Italy
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Genova
Italy
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Milano
Italy
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Modena
Italy
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Negrar
Italy
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Pavia
Italy
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Perugia
Italy
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Perugia
Italy
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Roma
Italy
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Rome
Italy
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Verona
Italy
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Vibo Valentia
Japan, Aichi
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Kasugai
Japan, Aichi
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Nagoya-shi
Japan, Aichi
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Toyoake Shi
Japan, Aichi
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Toyohashi-shi
Japan, Aichi
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Toyota-shi
Japan, Chiba
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Sakura-shi
Japan, Fukuoka
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Chikushino-shi
Japan, Fukuoka
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Kasuga-shi
Japan, Fukuoka
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Kitakyushu-shi
Japan, Fukuoka
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Kitakyushu-shi
Japan, Fukuoka
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Kitakyushu
Japan, Fukuoka
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Koga-shi
Japan, Fukuoka
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Kurume City
Japan, Fukushima
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Aizuwakamatsu-shi
Japan, Gifu
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Takayama-shi
Japan, Gunma
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Isesaki-shi
Japan, Hiroshima
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Aki-gun
Japan, Hiroshima
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Higashihiroshima-shi
Japan, Hiroshima
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Hiroshima-shi
Japan, Hyogo
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Kobe-City
Japan, Ishikawa
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Kanazawa
Japan, Ishikawa
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Komatsu
Japan, Kagoshima
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Kagoshima-shi
Japan, Kanagawa
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Kawasaki-city
Japan, Kanagawa
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Kawasaki
Japan, Miyagi
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Sendai-shi
Japan, Miyagi
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Sendai
Japan, Nagasaki
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Nagasaki-shi
Japan, Osaka
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Izumisano-shi
Japan, Osaka
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Kishiwada
Japan, Osaka
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Matsubara
Japan, Osaka
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Sakai-shi
Japan, Osaka
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Suita-shi
Japan, Osaka
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Suita
Japan, Saitama
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Hidaka
Japan, Tochigi
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Shimotsuke-shi
Japan, Tokyo
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Bunkyo-ku
Japan, Tokyo
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Hachioji
Japan, Tokyo
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Meguro-ku
Japan, Tokyo
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Minato-ku
Japan, Tokyo
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Minato-ku
Japan, Tokyo
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Mitaka-shi
Japan, Tokyo
Local Institution - 0298
Shinagawa-ku
Japan, Tokyo
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Shinjuku-Ku
Japan, Tokyo
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Tachikawa-shi
Japan, Yamaguchi
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Shimonoseki-Shi
Japan
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Fukuoka
Japan
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Fukuoka
Japan
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Kyoto
Japan
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Osaka
Japan
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Osaka
Japan
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Osaka
Japan
Local Institution
Saga
Korea, Republic of, Gyeonggido
Local Institution - 0094
Goyang-si
Korea, Republic of
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Anyang
Korea, Republic of
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Busan
Korea, Republic of
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Busan
Korea, Republic of
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Daegu
Korea, Republic of
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Daegu
Korea, Republic of
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Daegu
Korea, Republic of
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Gwangju
Korea, Republic of
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Incheon
Korea, Republic of
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Seongnam-si
Korea, Republic of
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Seoul
Korea, Republic of
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Seoul
Korea, Republic of
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Seoul
Korea, Republic of
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Seoul
Korea, Republic of
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Seoul
Korea, Republic of
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Seoul
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Seoul
Korea, Republic of
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Seoul
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Seoul
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Seoul
Mexico, Distrito Federal
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Ciudad de Mexico
Mexico, Distrito Federal
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Mexico
Mexico, Jalisco
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Guadalajara
Mexico, Nuevo LEON
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Monterrey
Mexico, Sinaloa
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Culiacan
Mexico
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Durango
Norway
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Bergen
Norway
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Grålum
Norway
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Kristiansand
Norway
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Lørenskog
Norway
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Oslo
Norway
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Stavanger
Poland
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Bydgoszcz
Poland
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Chelm
Poland
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Gdansk
Poland
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Grodzisk Mazowieciki
Poland
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Katowice
Poland
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Konskie
Poland
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Lodz
Poland
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Olsztyn
Poland
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Sandomierz
Poland
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Skarzysko-Kamienna
Poland
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Walcz
Poland
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Warszawa
Poland
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Warszawa
Poland
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Warszawa
Poland
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Wejherowo
Russian Federation
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Barnaul
Russian Federation
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Kemerovo
Russian Federation
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Moscow
Russian Federation
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Moscow
Russian Federation
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Novosibirsk
Russian Federation
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Smolensk
Russian Federation
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St. Petersburg
Russian Federation
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Yaroslavl
Spain, Castilla Y León
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León
Spain
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A Coruna
Spain
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Albacete
Spain
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Badalona
Spain
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Barcelona
Spain
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Barcelona
Spain
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Barcelona
Spain
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Córdoba
Spain
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Girona
Spain
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L'Hospitalet de Llobregat
Spain
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Lleida
Spain
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Madrid
Spain
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Madrid
Spain
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Madrid
Spain
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Madrid
Spain
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Sabadell, Barcelona
Spain
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San Sebastian
Spain
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Spain
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Santiago de Compostela
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Sevilla
Spain
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Sevilla
Spain
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Spain
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Terrassa
Spain
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Spain
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Spain
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Vigo
Sweden, Skane Lan
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Malmö
Sweden
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Sweden
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Sweden
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Umea
Sweden
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Switzerland
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Switzerland
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Switzerland
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Switzerland
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Bristol-Myers Squibb
Janssen, LP
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb