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Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Sponsor: GlaxoSmithKline
Summary
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
Official title: A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
892
Start Date
2023-08-01
Completion Date
2031-03-27
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Dostarlimab
Dostarlimab will be administered.
CAPEOX
CAPEOX will be administered.
FOLFOX
FOLFOX will be administered.
Locations (266)
GSK Investigational Site
Tucson, Arizona, United States
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Los Angeles, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Naperville, Illinois, United States
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Naperville, Illinois, United States
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Westwood, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bethesda, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Joplin, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Richmond, Virginia, United States
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Appleton, Wisconsin, United States
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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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Capital Federal, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Newcastle, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Woolangabba, Queensland, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Aalst, Belgium
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Belém, Brazil
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Campo Grande, Brazil
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Lages, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Teresina, Brazil
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Vitória, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Jinan, China
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Kunming, China
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Meizhou, China
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Nanchang, China
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Nanchang, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Taiyuan, China
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Tianjin, China
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Wuhan, China
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Xiamen, China
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Yangzhou, China
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Zhengzhou, China
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Hradec Králové, Czechia
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Nový Jičín, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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Lyon, France
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Marseille, France
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Nantes, France
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Paris, France
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Pessac, France
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Rennes, France
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Rouen, France
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Saint-Priest-en-Jarez, France
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Suresnes, France
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Toulouse, France
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Villejuif, France
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Berlin, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Halle, Germany
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Lübeck, Germany
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Mannheim, Germany
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München, Germany
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München, Germany
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Athens, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Bengaluru, Karnataka, India
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Ludhiana, Punjab, India
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Belagavi, India
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Hyderabad, India
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Nashik, India
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Pune, India
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Cagliari, Italy
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Genova, Italy
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Milan, Italy
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Naples, Italy
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Padova, Italy
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Pisa, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Roma, Italy
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Rozzano MI, Italy
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Aichi, Japan
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Chiba, Japan
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Fukuoka, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Kanagawa, Japan
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Kanagawa, Japan
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Kyoto, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Tokyo, Japan
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DF, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Oaxaca City, Mexico
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San Pedro Garza García, Mexico
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Tijuana, Mexico
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Breda, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Utrecht, Netherlands
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Bergen, Norway
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Kristiansand, Norway
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Lrenskog, Norway
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Oslo, Norway
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Stavanger, Norway
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Tromsø, Norway
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Punta Pacifica Panama City Panama, Panama
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Bydgoszcz, Poland
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Warsaw, Poland
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Almada, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Daegu, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Badajoz, Spain
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BaracaldoVizcaya, 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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Donostia / San Sebastian, Spain
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Elche Alicante, Spain
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Granada, Spain
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Jaén, Spain
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L'Hospitalet de Llobrega, Spain
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Las Palmas de Gran Canar, 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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Madrid, 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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Málaga, Spain
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Oviedo, Spain
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Pamplona, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Eskilstuna, Sweden
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Gothenburg, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Birmingham, United Kingdom
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Chelmsford, United Kingdom
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Cheltenham, United Kingdom
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Edinburgh, United Kingdom
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Hull, United Kingdom
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Leeds West Yorkshire, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
GSK Investigational Site
Sutton, United Kingdom