GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
NCT ID: NCT00252876
Last Updated: 2008-03-17
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
2000 participants
INTERVENTIONAL
2005-03-31
2007-01-31
Brief Summary
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GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
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GALLANT 22 Tesaglitazar vs. Placebo
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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tesaglitazar
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 randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.
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, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified on 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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AstraZeneca 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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Carlisle, Arkansas, United States
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Sherwood, Arkansas, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Huntington 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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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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Sacramento, 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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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, 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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Brunswick, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Evansville, Indiana, United States
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Witchita, Kansas, United States
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Bossier City, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Kalamazoo, Michigan, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Hamilton, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Rochester, 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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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Simpsonville, South Carolina, United States
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Morristown, Tennessee, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, 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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Tacoma, Washington, 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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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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Salta - Salta, , 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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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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Coquitlam, British Columbia, Canada
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Surrey, 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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Bolton, Ontario, Canada
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Brampton, 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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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Smith Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Chomedey-Laval, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, 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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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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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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Athens, , Greece
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Piraeus, , Greece
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Hong Kong, , Hong Kong
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Győr, , 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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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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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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Kubang Kerian, Kota Bharu, Malaysia
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George Town, , Malaysia
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Kuala Lumpur, , Malaysia
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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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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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Katowice, Ochojec, Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , 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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Dolný Kubín, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Ľubochňa, , Slovakia
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Nové Zámky, , Slovakia
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Považská Bystrica, , Slovakia
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Šahy, , Slovakia
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Trenčín, , 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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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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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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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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Coventry, , 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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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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Plymouth, , United Kingdom
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Radstock, , United Kingdom
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Shrewsbury, , United Kingdom
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Surrey, , United Kingdom
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West Bromwich, , 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
Countries
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Other Identifiers
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GALLEX 1
Identifier Type: -
Identifier Source: secondary_id
D6160C00038
Identifier Type: -
Identifier Source: org_study_id
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