GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
NCT ID: NCT01316939
Last Updated: 2017-09-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
229 participants
INTERVENTIONAL
2011-05-09
2013-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Placebo
GSK1605786A once daily
500 milligrams once daily
GSK1605786A
GSK1605786A 500 milligrams once daily
GSK1605786A twice daily
500 milligrams twice daily
GSK1605786A
GSK1605786A 500 milligrams twice daily
Interventions
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GSK1605786A
GSK1605786A 500 milligrams once daily
Placebo
Placebo
GSK1605786A
GSK1605786A 500 milligrams twice daily
Eligibility Criteria
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Inclusion Criteria
* Written informed consent prior to any CCX114157 specific study procedures
* Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent
* Stable doses of Crohn's disease medications
* Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study
Exclusion Criteria
* Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
* Known or suspected fixed symptomatic small bowel stricture
* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
* Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks
* Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Little Rock, Arizona, United States
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Tucson, Arizona, United States
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La Jolla, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Hamden, Connecticut, 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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Jacksonville, Florida, United States
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Port Orange, Florida, United States
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Atlanta, Georgia, United States
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Suwanee, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Hammond, Louisiana, United States
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Monroe, Louisiana, United States
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Chevy Chase, Maryland, United States
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Towson, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Chesterfield, Michigan, United States
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Troy, Michigan, United States
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Rochester, Minnesota, United States
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Lee's Summit, Missouri, United States
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Mexico, Missouri, United States
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Brooklyn, New York, United States
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East Setauket, New York, United States
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Great Neck, New York, United States
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Lake Success, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Ogden, Utah, United States
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Christiansburg, Virginia, United States
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Danville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Bankstown, New South Wales, Australia
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Hersten, Queensland, Australia
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Adelaide, South Australia, Australia
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Kurralta Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Prahran, Victoria, Australia
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Fremantle, Western Australia, Australia
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Hall in Tirol, , Austria
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Linz, , Austria
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Oberpullendorf, , Austria
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St.Veit/Glan, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Bonheiden, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Viña del Mar, , Chile
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Ostrava - Vitkovice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Herlev, , Denmark
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Hvidovre, , Denmark
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Odense, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Clichy, , France
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Lille, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Pessac, , France
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Saint-Priest-en-Jarez, , France
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Vandœuvre-lès-Nancy, , France
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Ulm, Baden-Wurttemberg, Germany
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Frankfurt am Main, Hesse, Germany
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Brinkum/Stuhr, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Minden, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hong Kong, , Hong Kong
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Shatin, New Territories, , Hong Kong
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Mosonmagyaróvár, , Hungary
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Szekszárd, , Hungary
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Vác, , Hungary
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Afula, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Palermo, Sicily, Italy
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Genova, , Italy
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Modena, , Italy
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Roma, , Italy
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Roma, , Italy
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Kagoshima, , Japan
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Kagoshima, , Japan
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Miyagi, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Ede, , Netherlands
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Eindhoven, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Dunedin, , New Zealand
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Lower Hutt, , New Zealand
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Otahuhu, Auckland, , New Zealand
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Tauranga, , New Zealand
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Tromsø, , Norway
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Tønsberg, , Norway
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Lublin, , Poland
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Sopot, , Poland
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Torun, , Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Viseu, , Portugal
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Irkutsk, , Russia
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Kazan', , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Tomsk, , Russia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Prešov, , Slovakia
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Trnava, , Slovakia
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Bellville, , South Africa
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Claremont, , South Africa
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Observatory, , South Africa
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Parktown, , South Africa
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Daegu, , South Korea
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Pusan, , 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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Seoul, , South Korea
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Wŏnju, , South Korea
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Badalona, , Spain
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Elche, , Spain
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Fuenlabrada (Madrid), , Spain
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Galdakao/Vizcaya, , 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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Marbella, , Spain
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Sabadell (Barcelona), , Spain
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Santander (Cantabria), , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Bern, , Switzerland
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Zurich, , Switzerland
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Taichung, , Taiwan
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Ankara, , Turkey (Türkiye)
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Vinnytsia, , Ukraine
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Harrow, Middlesex, United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Edinburgh, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Oxford, , United Kingdom
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Salford, , United Kingdom
Countries
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Other Identifiers
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2010-022383-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
114157
Identifier Type: -
Identifier Source: org_study_id
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