G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

NCT ID: NCT00255645

Last Updated: 2008-03-17

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

TERMINATED

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-12-31

Brief Summary

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This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Provision of a written informed consent
* Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Exclusion Criteria

* Received open-label treatment with tesaglitazar (since this is a post-treatment study)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstrasZeneca 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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Searcy, Arizona, United States

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Sierra Vista, Arizona, United States

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Tucson, Arizona, United States

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Carlisle, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Sherwood, Arkansas, United States

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Anaheim, California, United States

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Carmichael, California, United States

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Chula Vista, 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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Escondido, California, United States

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Fresno, California, United States

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Greenbrae, 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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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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Orange, 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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San Diego, 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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Colorado Springs, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, 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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Clearwater, 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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Palm Harbor, 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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Brunswick, Georgia, 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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Boise, Idaho, United States

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Berwyn, Illinois, United States

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Chicago, Illinois, United States

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Chicago Heights, 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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Springfield, Illinois, United States

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Sterling, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Waterloo, Iowa, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Bossier City, Louisiana, 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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Cadillac, Michigan, United States

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Kalamazoo, 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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St Louis, Missouri, United States

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Omaha, Nebraska, 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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Dover, New Hampshire, United States

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Hamilton, New Jersey, United States

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Pleasantville, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Flushing, New York, United States

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Manlius, New York, United States

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New Hyde Park, 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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Rochester, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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White Plains, 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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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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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, 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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Cheswick, 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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Columbia, 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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Memphis, Tennessee, United States

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Morristown, Tennessee, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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North Richland Hills, Texas, United States

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Roseland, 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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Burke, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Bellevue, Washington, United States

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Gig Harbor, Washington, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Huntington, West Virginia, United States

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Madison, Wisconsin, United States

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Menomonee Falls, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Morón, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Salta, Salta Province, Argentina

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Ciudad de Buenos Aires, , Argentina

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Rosario, , Argentina

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Adelaide, , Australia

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Brisbane, , Australia

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Cairns, , Australia

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Geelong, , Australia

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Melbourne, , Australia

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Perth, , Australia

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Sydney, , Australia

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Tasmania, , Australia

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Antwerp, , Belgium

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Braine-l'Alleud, , Belgium

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Hasselt, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Sint-Gillis-Waas, , Belgium

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Steenokkerzeel, , Belgium

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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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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Abbotsford, British Columbia, Canada

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Coquitlam, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Mount Pearl, 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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Truro, Nova Scotia, Canada

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Windzor, Nova Scotia, Canada

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Bolton, Ontario, Canada

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Brampton, Ontario, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Hastings, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Napanee, Ontario, Canada

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Niagara Falls, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Smith Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, 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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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Brno, , Czechia

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Hodonín, , Czechia

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Hradec Králové, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Příbram, , Czechia

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Semily, , Czechia

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Tábor, , Czechia

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Ústí nad Labem, , Czechia

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Paide, , Estonia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Viljandi, , Estonia

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Imatra, , Finland

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Jakobstad, , Finland

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Joensuu, , Finland

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Kauniainen, , Finland

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Kokkola, , Finland

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Kouvola, , Finland

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Kuopio, , Finland

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Lahti, , Finland

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Mikkeli, , Finland

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Oulu, , Finland

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Pori, , Finland

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Salo, , Finland

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Seinäjoki, , Finland

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Tampere, , Finland

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Turku, , Finland

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Vaasa, , Finland

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Vantaa, , Finland

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Ambriere Les Vallees, , France

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Angers, , France

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Béziers, , France

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Briey, , France

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Broglie, , France

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Château-Gontier, , France

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Cremeaux, , France

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Fontaine Saint Martin, , France

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Gan, , France

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Hyères, , France

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Jarny, , France

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La Garde, , France

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La Seyne-sur-Mer, , France

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Lambersat, , France

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Laval, , France

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Le Brusc, , France

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Le Lavandou, , France

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Lille, , France

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Lomme, , France

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Marignane, , France

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Mars Da Tour, , France

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Mayenne, , France

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Metz, , France

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Mondelange, , France

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Montbrison, , France

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Montpellier, , France

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Montrevault, , France

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Moûtiers, , France

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Nantes, , France

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Paris, , France

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Poitiers, , France

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Roanne, , France

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Roquevaire, , France

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Saint-Chamond, , France

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Saint-Cyr, , France

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Saint-Jean-de-Luz, , France

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Six-Fours-les-Plages, , France

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Tantonville, , France

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Tiercé, , France

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Toulon, , France

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Toulouse, , France

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Aschaffenburg, , Germany

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Beckum, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Ehrenberg, , Germany

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Essen, , Germany

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Gelnhausen, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Hermaringen, , Germany

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Künzing, , Germany

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Langen, , Germany

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Mannheim, , Germany

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Marl, , Germany

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Nürberg, , Germany

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Pirna, , Germany

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Rotenburg/Fulda, , Germany

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Athens, , Greece

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Piraeus, , Greece

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Hong Kong, , Hong Kong

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Shatin, N.T., , Hong Kong

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Gy?r, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Siófok, , Hungary

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Székesfehérvár, , Hungary

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Bangalore, , India

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Hyderabad, , India

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Mumbai, , India

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New Delhi, , India

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Jakarta, , Indonesia

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Malang, , Indonesia

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Ashkelon, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Rishon LeZiyyon, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Arenzano, , Italy

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Chiavari (GE), , Italy

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Chieri, , Italy

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Florence, , Italy

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Gubbio (PG), , Italy

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Messina, , Italy

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Milan, , Italy

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Monteccio Emilia, , Italy

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Napoli, , Italy

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Padua, , Italy

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Perugia, , Italy

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Pescara, , Italy

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Piacenza, , Italy

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Pistoia, , Italy

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Reggio Calabria, , Italy

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Reggio Emilia, , Italy

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Roma, , Italy

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Scandiano, , Italy

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Udine, , Italy

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Daugavpils, , Latvia

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Jēkabpils, , Latvia

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Madona, , Latvia

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Riga, , Latvia

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Sigulda, , Latvia

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Talsi, , Latvia

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Valmiera, , Latvia

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Vilnius, , Lithuania

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George Town, , Malaysia

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Kuala Lumpur, , Malaysia

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Kubang Kerian, Kota Bharu, , Malaysia

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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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Torreón, , Mexico

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Veracruz, Veracruz, , Mexico

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Zapopan , Jalisco, , Mexico

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Beek en Donk, , Netherlands

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Bennebroek, , Netherlands

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Deurne, , Netherlands

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Huizen, , Netherlands

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Losser, , Netherlands

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Nijverdal, , Netherlands

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Rijswijk, , Netherlands

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Roelofarendsveen, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Aursmoen, , Norway

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Ås, , Norway

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Bergen, , Norway

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Elverum, , Norway

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Enebakk, , Norway

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Fredrikstad, , Norway

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Hamar, , Norway

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Haugesund, , Norway

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Horten, , Norway

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Hønefoss, , Norway

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Inderøy, , Norway

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Kongsberg, , Norway

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Larvik, , Norway

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Lena, , Norway

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Lierskogen, , Norway

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Lysaker, , Norway

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Oslo, , Norway

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Rolvsøy, , Norway

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Rud, , Norway

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Soerumsand, , Norway

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Stavanger, , Norway

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Straume, , Norway

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Trondheim, , Norway

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Østerås, , Norway

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Cebu City, , Philippines

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Makati, , Philippines

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Manila, , Philippines

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Marikina City, , Philippines

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Pasig, , Philippines

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Quezon City, , Philippines

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Katowice - Ochojec, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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P³ock, , Poland

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Poznan, , Poland

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Radom, , Poland

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Rzeszów, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Toruñ, , Poland

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Tychy, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zielona Góra, , Poland

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Almada, , Portugal

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Amadora, , Portugal

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Elvas, , Portugal

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Lisbon, , Portugal

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Portalegre, , Portugal

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Moscow, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Belgrade, , Serbia and Montenegro

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Singapore, , Singapore

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Ilava, , Slovakia

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Košice, , Slovakia

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Kysucké Nové Mesto, , Slovakia

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Levice, , Slovakia

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Lučenec, , Slovakia

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Ľubochňa, , Slovakia

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Nitra, , Slovakia

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Nové Zámky, , Slovakia

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Považská Bystrica, , Slovakia

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Prešov, , Slovakia

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Šahy, , Slovakia

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Trenčín, , Slovakia

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Trnava, , Slovakia

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Veľký Meder, , Slovakia

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Žilina, , Slovakia

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Cape Town, , South Africa

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Chatsworth, , South Africa

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Durban, , South Africa

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Gauteng, , South Africa

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Houghton Gauteng, , South Africa

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Johannesburg, , South Africa

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Pretoria, , South Africa

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Seoul, , South Korea

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Suwon, , South Korea

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Barcelona, , Spain

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Begonte (Lugo), , Spain

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Guissona (Lleida), , Spain

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Madrid, , Spain

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San Sebastián de los Reyes, , Spain

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San Vicente de Raspeig (Alicante), , Spain

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Seville, , Spain

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Valencia, , Spain

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Villar Del Arzobispo (Valencia), , Spain

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Åmål, , Sweden

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Borås, , Sweden

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Dalby, , Sweden

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Gothenburg, , Sweden

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Höganäs, , Sweden

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Malmo, , Sweden

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Mölndal, , Sweden

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Partille, , Sweden

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Skene, , Sweden

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Skrivarp, , Sweden

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Stenungsund, , Sweden

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Uddevalla, , Sweden

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Uppsala, , Sweden

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Vänersborg, , Sweden

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Bern, , Switzerland

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Ilanz, , Switzerland

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Lausanne, , Switzerland

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Monthey, , Switzerland

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Zurich, , Switzerland

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Changhua, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Aberdeen, , United Kingdom

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Atherstone, , United Kingdom

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Ayr, , United Kingdom

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Bath, , United Kingdom

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Belfast, , United Kingdom

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Berks, , United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Bucks, , 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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Coventry, , United Kingdom

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Dublin, , United Kingdom

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Dundee, , 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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Liverpool, , United Kingdom

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Manchester, , United Kingdom

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Northampton, , United Kingdom

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Pembrokeshire, , United Kingdom

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Plymouth, , United Kingdom

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Radstock, , United Kingdom

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Reading, , United Kingdom

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Shrewsbury, , United Kingdom

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Surrey, , United Kingdom

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West Midlands, , United Kingdom

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Wiltshire, , United Kingdom

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Wrexham, , United Kingdom

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Argentina Australia Belgium Brazil Canada Czechia Estonia Finland France Germany Greece Hong Kong Hungary India Indonesia Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Norway Philippines Poland Portugal Russia Serbia and Montenegro Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand United Kingdom Vietnam

Other Identifiers

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EudraCT No 2005-001373-97

Identifier Type: -

Identifier Source: secondary_id

D6160C00056

Identifier Type: -

Identifier Source: org_study_id

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