Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
NCT ID: NCT01242514
Last Updated: 2014-04-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1917 participants
INTERVENTIONAL
2011-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Oral treatment
Fostamatinib
Fostamatinib 100mg twice daily
B
Oral treatment
Fostamatinib
Fostamatinib 150mg once daily
C
Oral treatment
Fostamatinib
Fostamatinib 100mg once daily
Interventions
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Fostamatinib
Fostamatinib 100mg twice daily
Fostamatinib
Fostamatinib 150mg once daily
Fostamatinib
Fostamatinib 100mg once daily
Eligibility Criteria
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Inclusion Criteria
* Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).
Exclusion Criteria
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Significant liver function test abnormalities or physical symptoms of hepatotoxicity
* Significant infection
* Gastrointestinal intolerance
* Cancer
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris O'Brien, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Anaheim, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Palo Alto, California, United States
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Roseville, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Danbury, Connecticut, United States
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Trumbull, Connecticut, United States
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Lewes, Delaware, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pinellas Park, Florida, United States
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Tampa, Florida, United States
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Tavares, Florida, United States
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Venice, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Cedar Rapids, Iowa, United States
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Bowling Green, Kentucky, United States
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Elizabethtown, Kentucky, United States
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Cumberland, Maryland, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Oxon Hill, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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Worcester, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Eagan, Minnesota, United States
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Flowood, Mississippi, United States
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Florissant, Missouri, United States
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Richmond Heights, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Freehold, New Jersey, United States
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Albuquerque, New Mexico, United States
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Las Cruces, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Cooperstown, New York, United States
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Olean, New York, United States
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Roslyn, New York, United States
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Smithtown, New York, United States
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Syracuse, New York, United States
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Asheville, 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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Greensboro, North Carolina, United States
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Research Triangle Park, North Carolina, United States
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Dayton, Ohio, United States
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Mayfield Village, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Waxford, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Orangeburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Hixson, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Nassau Bay, Texas, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Ciudad Autonoma Bs As, CBA, Argentina
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Córdoba, CRD, Argentina
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San Juan, San Juan Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, TUC, Argentina
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Caba Buenos Aires, , Argentina
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Ciudad Autonoma Bs As, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Quilmes, , Argentina
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Camperdown, New South Wales, Australia
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Southport, Queensland, Australia
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Cairns, , Australia
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Ghent, Belgium, Belgium
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Liège, Belgium, Belgium
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Brussels, , Belgium
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Gilly, , Belgium
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Yvoir, , Belgium
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Bowmanville, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, 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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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Osorno, Los Lagos Region, Chile
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Santiago, , Chile
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Brno, , Czechia
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Bruntál, , Czechia
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Česká Lípa, , Czechia
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České Budějovice, , Czechia
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Hlučín, , Czechia
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Hostivice, , Czechia
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Kladno, , Czechia
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Liberec, , Czechia
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Ostrava, , Czechia
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Ostrava - Trebovice, , Czechia
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Prague, , Czechia
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Sokolov, , Czechia
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Terezín, , Czechia
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Zlín, , Czechia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Orléans, , France
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Aachen, North Rhine-Westphalia, Germany
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Halle, Saxony, Germany
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Cologne, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Herne, , Germany
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Leipzig, , Germany
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München, , Germany
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Makó, , Hungary
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Sopron, , Hungary
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Szentes, , Hungary
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Zalaegerszeg-pozva, , Hungary
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Gandhinagar, Gujarat, India
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Vadodara, Gujarat, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Udupi, Karnataka, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Nagpur, Maharshtra, India
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Coimbatore, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Ashkelon, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Iesi, AN, Italy
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Udine, UD, Italy
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Varese, VA, Italy
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Liepāja, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Šiauliai, , Lithuania
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Chihuahua City, Chihuahua, Mexico
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Saltillo, Coahuila, Mexico
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Mexicali, Estado de Baja California, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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San Luis Potosi, Mexico, Mexico
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Monterrey, Nuevo León, Mexico
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Obrergon, Sonora, Mexico
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Pueblo Libre, Lima region, Peru
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San Borja, Lima region, Peru
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San Isidro, Lima region, Peru
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Bytom, , Poland
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Chełm Śląski, , Poland
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Grodzisk Mazowiecki, , Poland
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Kalisz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Żyrardów, , Poland
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Aveiro, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Ploieşti, Prahova, Romania
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Brăila, , Romania
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Petrozavodsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niška Banja, , Serbia
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Novi Sad, , Serbia
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Bratislava, Slovakia, Slovakia
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Žilina, Slovakia, Slovakia
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Poprad, , Slovakia
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Rimavská Sobota, , Slovakia
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Ružomberok, , Slovakia
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Trnava, , Slovakia
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Panorama, Cape Town, South Africa
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Port Elizabeth, E Cape, South Africa
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Kempron Park, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Stellenbosch, , South Africa
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Mérida, Extremadura, Spain
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Barcelona, , Spain
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Luhansk, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporyzhzhya, , Ukraine
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Bracknell, Berkshire, United Kingdom
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Warrington, Cheshire, United Kingdom
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London, Greater London, United Kingdom
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Maidstone, Kent, United Kingdom
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Eastbourne, Sussex, United Kingdom
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Solihull, West Midlands, United Kingdom
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Basingstoke, , United Kingdom
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Cambridge, , United Kingdom
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Christchurch, , United Kingdom
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Ipswich, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Nottingham, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Westcliff-on-the Sea, , United Kingdom
Countries
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Other Identifiers
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2010-020892-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4300C00005
Identifier Type: -
Identifier Source: org_study_id
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