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Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

NCT ID: NCT00106808

Last Updated: 2010-09-14

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

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

Detailed Description

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Conditions

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Type 2 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

Pioglitazone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes
* HbA1c \> = 8.0% and \< = 12.0%
* Serum triglyceride concentration \< = 600 mg/dL
* Fasting c-peptide \> = 1.0 ng/ml
* Body mass index \< = 41 kg/m2
* Drug naive patients

Exclusion Criteria

* History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
* Women of child Bearing Potential
* Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
* History of renal disease, bladder cancer, 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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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Halifax, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Laval, Quebec, Canada

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Longueuil, Quebec, Canada

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Santiago, Región de Valparaíso, Chile

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Bangalore, , India

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Chennai, , India

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Hyderabad, , India

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Kolkata, , India

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Guama, São Paulo, Brazil

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Paulistânia, São Paulo, Brazil

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Rua Maestro, São Paulo, Brazil

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Ruo Maestro Cardim, São Paulo, Brazil

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Vila Mariana, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Antigonish, Nova Scotia, Canada

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Madison, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Beverly Hills, California, United States

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Concord, California, United States

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Encinitas, California, United States

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Fresno, 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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Orange, California, United States

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Pasadena, California, United States

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Roseville, California, United States

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Santa Monica, California, United States

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Colorado Springs, Colorado, United States

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Wilmington, Delaware, United States

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Boynton Beach, Florida, United States

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Charlotte Harbour, Florida, United States

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Chipley, Florida, United States

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Destin, Florida, United States

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Holly Hill, Florida, United States

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Jacksonville, 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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Niceville, Florida, United States

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Panama City, Florida, United States

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Port Charlotte, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Calhoun, Georgia, United States

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Carrollton, Georgia, United States

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Dunwoody, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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North Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, 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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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Cantonville, Maryland, United States

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Towson, Maryland, United States

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Westminister, Maryland, United States

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Swansea, Massachusetts, United States

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Cadillac, Michigan, United States

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Portage, Michigan, United States

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Richland, Michigan, United States

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Gulfport, Mississippi, United States

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Tupelo, 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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Butte, Montana, United States

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Missoula, Montana, United States

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Bridgewater, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Binghamton, New York, United States

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Johnson City, New York, United States

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Mineola, New York, United States

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Northport, New York, United States

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Charlotte, 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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Morehead City, 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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Barberton, Ohio, United States

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Bellbrook, Ohio, United States

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Canal Fulton, Ohio, United States

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Canfield, Ohio, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Mentor, Ohio, United States

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Youngstown, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philipsburg, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Fayetteville, Tennessee, United States

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Memphis, Tennessee, United States

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Selmer, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Midland, Texas, United States

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New Braunfels, Texas, United States

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Pearland, Texas, United States

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Rosenberg, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Salem, Virginia, United States

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Spokane, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Chacabuco, Chaco Province, Argentina

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Corrientes, Corrientes Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Broadmeadow, New South Wales, Australia

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Concord, New South Wales, Australia

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Randwick, New South Wales, Australia

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Westmead, New South Wales, Australia

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Brisbane, Queensland, Australia

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Cairns, Queensland, Australia

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Daw Park, South Australia, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Freemantle, Western Australia, Australia

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B. Rodolfo Teofilo, Ceará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Cerq. Cesar, São Paulo, Brazil

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Mumbai, , India

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New Delhi, , India

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Vellore, , India

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Aguascalientes, Aguascalientes, Mexico

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Chihuahua City, Chihuahua, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Morelia, Michioacan, Mexico

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Monterrey, Nuevo León, Mexico

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Lima, , Peru

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Cebu, , Philippines

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Las Piñas, , Philippines

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Manila, , Philippines

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Pasig, , Philippines

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Quezon, , Philippines

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Quezon City, , Philippines

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Kirov, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Yaroslavl, , Russia

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taoyuan Hsien, , Taiwan

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Bangkok, , Thailand

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Kong Kaen, , Thailand

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Songkhla, , Thailand

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Taipei City, , Thailand

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Dniepropetrovsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Countries

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United States Argentina Australia Brazil Canada Chile India Mexico Peru Philippines Russia Taiwan Thailand Ukraine

Other Identifiers

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CV168-062

Identifier Type: -

Identifier Source: org_study_id