Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
399 participants
INTERVENTIONAL
2011-04-01
2013-10-29
Brief Summary
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GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
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A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
NCT01277666
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
NCT01536418
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Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
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Detailed Description
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1. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
2. completion of maintenance study CCX114157 at Week 52
3. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change.
The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability.
It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.
The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.
Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GSK1605786A
500 milligrams twice daily
GSK1605786A
500 milligrams twice daily
Interventions
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GSK1605786A
500 milligrams twice daily
Eligibility Criteria
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Inclusion Criteria
* Written informed consent prior to any study-specific procedures
* Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate
Exclusion Criteria
* Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
* Fixed symptomatic stenoses or strictures of small bowel or colon
* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
* Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
* Evidence of hepatic dysfunction or viral hepatitis
* Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.
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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Anaheim, California, 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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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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Genoa, Liguria, Italy
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Palermo, Sicily, Italy
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Modena, , 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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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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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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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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Busan, , South Korea
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Daegu, , 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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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, , 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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2010-022384-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
114644
Identifier Type: -
Identifier Source: org_study_id
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