GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00226330
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1100 participants
INTERVENTIONAL
2005-03-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tesaglitazar
(0.5 or 1 mg)
Pioglitazone
(15, 30 or 45 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men or women who are \>= 18 years of age
* Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
* Completed the last two visits of the randomized treatment period in GALLANT 6
Exclusion Criteria
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
* Creatinine levels of above twice the normal range
* Creatine kinase of above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Galida Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Sierra Vista, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Dinuba, California, United States
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Elk Grove, California, United States
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Encinitas, California, United States
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Encino, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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Redondo Beach, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Brandon, Florida, United States
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Cooper City, Florida, United States
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Delray Beach, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Dunwoody, Georgia, United States
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Berwyn, Illinois, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Gurnee, Illinois, United States
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Melrose Park, Illinois, United States
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North Chicago, Illinois, United States
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Peoria, Illinois, United States
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Sterling, Illinois, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Waterloo, Iowa, United States
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Topeka, Kansas, United States
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Witchita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Slidell, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Haverhill, Massachusetts, United States
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Petoskey, Michigan, United States
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Excelsior Springs, Missouri, United States
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Richmond Heights, Missouri, United States
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Rolla, Missouri, United States
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Las Vegas, Nevada, United States
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North Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Reno, Nevada, United States
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Pleasantville, New Jersey, United States
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Manlius, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Staten Island, New York, United States
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Asheville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Lakewood, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Gig Harbor, Washington, United States
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Huntington, West Virginia, United States
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Morón, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba - Córdoba, , Argentina
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Rosario, , Argentina
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Salta - Salta, , Argentina
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Chilliwack, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Dartmouth, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Windsor, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Kingston, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Oshawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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St. Catharines, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Helsinki, , Finland
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Jakobstad, , Finland
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Kauniainen, , Finland
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Kuopio, , Finland
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Pori, , Finland
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Tampere, , Finland
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Guadalajara, Jalisco., , Mexico
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México, D.F., , Mexico
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Nuevo León, Monterrey, , Mexico
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Puebla, Mexico, , Mexico
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Torreón, , Mexico
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Zapopan, , Mexico
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Belfast, , United Kingdom
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Cardiff, , United Kingdom
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Co Antrim N Ireland, , United Kingdom
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Co. Wexford, Ireland, , United Kingdom
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Dublin, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Kent, , United Kingdom
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Leeds, , United Kingdom
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Mid Glamorgan, , United Kingdom
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Pembrokeshire, , United Kingdom
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Plymouth, , United Kingdom
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Reading, , United Kingdom
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Surrey, , United Kingdom
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Wiltshire, , United Kingdom
Countries
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Other Identifiers
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D6160C00048
Identifier Type: -
Identifier Source: org_study_id