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PPAR - Combination With Metformin

NCT ID: NCT00162240

Last Updated: 2012-04-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-05-31

Brief Summary

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A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Muraglitazar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes
* HbA1c \> - 7.0% and \< - 10.0 %
* Mean serum triglyceride \< - 600 mg/dL
* Body mass index \< - 41 kg/m2
* Fasting c-peptide \> - 1.0 ng/mL

Exclusion Criteria

* History of myocardial infarction (MI)
* coronary angioplasty or bypass graft(s)
* valvular disease or repair
* unstable angina pectoris
* transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
* Congestive heart failure NYHA Class III and IV
* Uncontrolled hypertension
* History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Haleyville, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fayette, Arkansas, United States

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Little Rock, Arkansas, United States

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Concord, California, United States

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Fountain Valley, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Mission Viejo, California, United States

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Pasadena, California, United States

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Rolling Hills Estate, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Loveland, Colorado, United States

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Wheat Ridge, Colorado, United States

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New Britain, Connecticut, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Chipley, Florida, United States

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Cooper City, Florida, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Columbus, Georgia, United States

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Dunwoody, Georgia, United States

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Honolulu, Hawaii, United States

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Overland Park, Kansas, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Richmond, Kentucky, United States

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Slidell, Louisiana, United States

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Chester, Maryland, United States

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Silver Spring, Maryland, United States

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Ayer, Massachusetts, United States

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Springfield, Massachusetts, United States

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Sudbury, Massachusetts, United States

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Lansing, Michigan, United States

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Arden Hills, Minnesota, United States

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Gulfport, Mississippi, United States

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Olive Branch, Mississippi, United States

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Rolling Fork, Mississippi, United States

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City of Saint Peters, Missouri, United States

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Excelsior Springs, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New Hyde Park, New York, United States

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West Seneca, New York, United States

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Westfield, New York, 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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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Huntersville, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, 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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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Corvallis, Oregon, United States

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Eugene, Oregon, United States

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Hillsboro, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Warminster, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Duncan, South Carolina, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lake Jackson, Texas, United States

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Lubbock, 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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Springfield, Virginia, United States

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Virginia Beach, Virginia, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Bahía Blanca, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Córdoba, Córdoba Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Canberra, New South Wales, Australia

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Sydney, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Brisbane, Queensland, Australia

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Meadowbrook, Queensland, Australia

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Perth, Western Australia, Australia

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Curitiba, Paraná, Brazil

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Belém, Pará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Calgary, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Manuels, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Oakville, Ontario, Canada

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Ottawa, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Fleurimont, Quebec, Canada

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Granby, Quebec, Canada

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Laval, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Albens, , France

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Broglie, , France

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Chartres, , France

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Fabrègues, , France

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Gémenos, , France

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Husseren-Wesserling, , France

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Labarthe-sur-Lèze, , France

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Rosiers-d'Égletons, , France

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Durango, Durango, Mexico

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Tijuana, Estado de Baja California, Mexico

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León, Guanajuato, Mexico

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Distrito Federal, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Cuernavaca, Morelos, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Arequipa, Arequipa, Peru

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Lima, Lima Province, Peru

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Añasco, , Puerto Rico

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Carolina, , Puerto Rico

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Guaynabo, , Puerto Rico

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Seoul, , South Korea

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Ängelholm, , Sweden

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Bjuv, , Sweden

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Enskede, , Sweden

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Farsta, , Sweden

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Jarfalla, , Sweden

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Landskrona, , Sweden

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Leksand, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Ödeshög, , Sweden

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Sävedalen, , Sweden

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Sjuntorp, , Sweden

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Stockholm, , Sweden

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Trollhättan, , Sweden

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Vällingby, , Sweden

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Carrickfergus, Antrim, United Kingdom

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Soham, Cambridgeshire, United Kingdom

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Doncaster, Derbyshire, United Kingdom

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Paignton, Devon, United Kingdom

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Bangor, Down, United Kingdom

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Downpatrick, Down, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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High Valleyfield, Fife, United Kingdom

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Sunbury-on-Thames, Greater London, United Kingdom

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Aldershot, Hampshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Farnworth, Lancashire, United Kingdom

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Harrow, Middlesex, United Kingdom

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Doncaster, North Yorkshire, United Kingdom

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Hastings, Sussex, United Kingdom

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Atherstone, Warwickshire, United Kingdom

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Nuneaton, Warwickshire, United Kingdom

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Bath, Wiltshire, United Kingdom

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Inkberrow, Worcestershire, United Kingdom

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Swan Lake, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada France Mexico Peru Puerto Rico South Korea Sweden United Kingdom

Other Identifiers

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CV168-022

Identifier Type: -

Identifier Source: org_study_id

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