- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255645
G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)
March 14, 2008 updated by: AstraZeneca
A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment
4500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ciudad de Buenos Aires, Argentina
- Research Site
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Córdoba, Argentina
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Rosario, Argentina
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Salta, Argentina
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Buenos Aires
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Moron, Buenos Aires, Argentina
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Quilmes, Buenos Aires, 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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Antwerpen, Belgium
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Braine-L'alleud, Belgium
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Hasselt, Belgium
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Liege, 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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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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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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Manitoba
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Winnipeg, Manitoba, Canada
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Newfoundland and Labrador
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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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Nova Scotia
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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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Ontario
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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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Scarborough, Ontario, Canada
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Smith Falls, Ontario, Canada
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St. Catherines, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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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, Czech Republic
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Hodonin, Czech Republic
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Hradec Kralove, Czech Republic
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Plzen, Czech Republic
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Praha, Czech Republic
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Pribram, Czech Republic
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Semily, Czech Republic
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Tabor, Czech Republic
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Usti nad Labem, Czech Republic
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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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Helsinki, Finland
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Hämeenlinna, Finland
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Imatra, 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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Pietarsaari, Finland
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Pori, Finland
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Salo, Finland
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Seinajoki, 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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Belgrade, Former Serbia and Montenegro
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Ambriere Les Vallees, France
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Angers, France
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Beziers, France
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Briey, France
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Broglie, France
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Château Gontier, France
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Crémeaux, France
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Fontaine St Martin, France
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Gan, France
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Hyeres, 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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Moutiers, 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 Jean de Luz, France
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Saint-Cyr, France
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Six Fours Les Plages, France
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St Chamond, France
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Tantonville, France
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Tierce, 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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Duesseldorf, 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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Hannover, 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
- Research Site
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Holon, Israel
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Jerusalem, Israel
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Rishon-Lezion, Israel
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Tel Aviv, Israel
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Tel Hashomer, Israel
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Zefat, Israel
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Arenzano, Italy
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Chiavari (GE), Italy
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Chieri, Italy
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Firenze, Italy
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Gubbio (PG), Italy
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Messina, Italy
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Milano, Italy
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Monteccio Emilia, Italy
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Napoli, Italy
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Padova, 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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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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Daugavpils, Latvia
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Jekabpils, 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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Kuala Lumpur, Malaysia
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Kubang Kerian, Kota Bharu, Malaysia
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Penang, 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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Torreon, 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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Den Haag, 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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Aurskog, 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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Ås, 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 City, 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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Poznan, Poland
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P³ock, Poland
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Radom, Poland
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Rzeszow, 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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Warszawa, Poland
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Wroclaw, Poland
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Zielona Gora, 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, Russian Federation
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St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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Singapore, Singapore
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Bratislava, Slovakia
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Dolny Kubin, Slovakia
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Ilava, Slovakia
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Kosice, Slovakia
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Kysucke Nove Mesto, Slovakia
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Levice, Slovakia
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Lubochna, Slovakia
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Lucenec, Slovakia
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Nitra, Slovakia
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Nove Zamky, Slovakia
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Povazska Bystrica, Slovakia
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Presov, Slovakia
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Sahy, Slovakia
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Trencin, Slovakia
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Trnava, Slovakia
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Velky Meder, Slovakia
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Zilina, 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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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 Sebastian de los Reyes, Spain
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San Vicente de Raspeig (Alicante), Spain
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Sevilla, Spain
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Valencia, Spain
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Villar del Arzobispo (Valencia), Spain
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Borås, Sweden
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Dalby, Sweden
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Göteborg, Sweden
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Höganäs, Sweden
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Malmö, 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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Åmål, 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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Zürich, 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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Alabama
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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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Arizona
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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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Arkansas
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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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California
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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
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Colorado Springs, Colorado, United States
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Wheat Ridge, Colorado, United States
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Connecticut
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Waterbury, Connecticut, United States
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Delaware
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Newark, Delaware, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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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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Georgia
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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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Hawaii
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Honolulu, Hawaii, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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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
- Research Site
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Melrose Park, Illinois, United States
- Research Site
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North Chicago, Illinois, United States
- Research Site
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Peoria, Illinois, United States
- Research Site
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Springfield, Illinois, United States
- Research Site
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Sterling, Illinois, United States
- Research Site
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Indiana
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Evansville, Indiana, United States
- Research Site
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Indianapolis, Indiana, United States
- Research Site
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Iowa
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Waterloo, Iowa, United States
- Research Site
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Kansas
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Topeka, Kansas, United States
- Research Site
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Wichita, Kansas, United States
- Research Site
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Kentucky
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Lexington, Kentucky, United States
- Research Site
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Louisville, Kentucky, United States
- Research Site
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Louisiana
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Bossier City, Louisiana, United States
- Research Site
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New Orleans, Louisiana, United States
- Research Site
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Slidell, Louisiana, United States
- Research Site
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Maryland
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Baltimore, Maryland, United States
- Research Site
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Columbia, Maryland, United States
- Research Site
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Massachusetts
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Haverhill, Massachusetts, United States
- Research Site
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Michigan
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Cadillac, Michigan, United States
- Research Site
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Kalamazoo, Michigan, United States
- Research Site
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Missouri
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Excelsior Springs, Missouri, United States
- Research Site
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Richmond Heights, Missouri, United States
- Research Site
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Rolla, Missouri, United States
- Research Site
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St Louis, Missouri, United States
- Research Site
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Nebraska
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Omaha, Nebraska, United States
- Research Site
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Nevada
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Las Vegas, Nevada, United States
- Research Site
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North Las Vegas, Nevada, United States
- Research Site
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Pahrump, Nevada, United States
- Research Site
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Reno, Nevada, United States
- Research Site
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New Hampshire
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Dover, New Hampshire, United States
- Research Site
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New Jersey
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Hamilton, New Jersey, United States
- Research Site
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Pleasantville, New Jersey, United States
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States
- Research Site
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New York
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Bronx, New York, United States
- Research Site
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Brooklyn, New York, United States
- Research Site
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Flushing, New York, United States
- Research Site
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Manlius, New York, United States
- Research Site
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New Hyde Park, New York, United States
- Research Site
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New York, New York, United States
- Research Site
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Olean, New York, United States
- Research Site
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Rochester, New York, United States
- Research Site
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Staten Island, New York, United States
- Research Site
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White Plains, New York, United States
- Research Site
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North Carolina
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Asheville, North Carolina, United States
- Research Site
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Charlotte, North Carolina, United States
- Research Site
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Wilmington, North Carolina, United States
- Research Site
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Winston-Salem, North Carolina, United States
- Research Site
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Cleveland, Ohio, United States
- Research Site
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Columbus, Ohio, United States
- Research Site
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Dayton, Ohio, United States
- Research Site
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Kettering, Ohio, United States
- Research Site
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Toledo, Ohio, United States
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Tulsa, Oklahoma, United States
- Research Site
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Oregon
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Medford, Oregon, United States
- Research Site
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Portland, Oregon, United States
- Research Site
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Pennsylvania
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Altoona, Pennsylvania, United States
- Research Site
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Cheswick, Pennsylvania, United States
- Research Site
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Erie, Pennsylvania, United States
- Research Site
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Philadelphia, Pennsylvania, United States
- Research Site
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Reading, Pennsylvania, United States
- Research Site
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Warminster, Pennsylvania, United States
- Research Site
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South Carolina
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Columbia, South Carolina, United States
- Research Site
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Greer, South Carolina, United States
- Research Site
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Simpsonville, South Carolina, United States
- Research Site
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Tennessee
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Memphis, Tennessee, United States
- Research Site
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Morristown, Tennessee, United States
- Research Site
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Texas
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Carrollton, Texas, United States
- Research Site
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Corpus Christi, Texas, United States
- Research Site
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Dallas, Texas, United States
- Research Site
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Fort Worth, Texas, United States
- Research Site
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Houston, Texas, United States
- Research Site
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Midland, Texas, United States
- Research Site
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North Richland Hills, Texas, United States
- Research Site
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Roseland, Texas, United States
- Research Site
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San Antonio, Texas, United States
- Research Site
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Utah
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Salt Lake City, Utah, United States
- Research Site
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Virginia
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Burke, Virginia, United States
- Research Site
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Norfolk, Virginia, United States
- Research Site
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Richmond, Virginia, United States
- Research Site
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Virginia Beach, Virginia, United States
- Research Site
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Washington
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Bellevue, Washington, United States
- Research Site
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Gig Harbor, Washington, United States
- Research Site
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Renton, Washington, United States
- Research Site
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Seattle, Washington, United States
- Research Site
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Spokane, Washington, United States
- Research Site
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Tacoma, Washington, United States
- Research Site
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West Virginia
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Huntington, West Virginia, United States
- Research Site
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Wisconsin
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Madison, Wisconsin, United States
- Research Site
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Menomonee Falls, Wisconsin, United States
- Research Site
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Milwaukee, Wisconsin, United States
- Research Site
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Hanoi, Vietnam
- Research Site
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Ho Chi Minh, Vietnam
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstrasZeneca Galida Medical Science Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
November 18, 2005
First Submitted That Met QC Criteria
November 18, 2005
First Posted (Estimate)
November 21, 2005
Study Record Updates
Last Update Posted (Estimate)
March 17, 2008
Last Update Submitted That Met QC Criteria
March 14, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6160C00056
- EudraCT No 2005-001373-97
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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