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

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1917 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Oral treatment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Fostamatinib 100mg twice daily

B

Oral treatment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Fostamatinib 150mg once daily

C

Oral treatment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Fostamatinib 100mg once daily

Interventions

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Fostamatinib

Fostamatinib 100mg twice daily

Intervention Type DRUG

Fostamatinib

Fostamatinib 150mg once daily

Intervention Type DRUG

Fostamatinib

Fostamatinib 100mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
* 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

* Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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United States Argentina Australia Belgium Brazil Bulgaria Canada Chile Colombia Czechia Estonia France Germany Hungary India Israel Italy Latvia Lithuania Mexico Peru Poland Portugal Romania Russia Serbia Slovakia South Africa Spain Ukraine United Kingdom

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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