Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)
July 9, 2014 updated by: AstraZeneca
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes
Study Type
Interventional
Enrollment (Actual)
18206
Phase
- Phase 4
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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Buenos Aires, Argentina
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Ciudad Autonom de Buenos Aires, Argentina
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CiudadAutonoma de Buenos Aires, Argentina
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Cordoba, Argentina
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Corrientes, Argentina
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La Plata, Argentina
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Lanus Buenos Aires, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Morón, Argentina
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Ramos Mejía, Argentina
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Rosario, Argentina
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Rosario Santa Fe, Argentina
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Santa Fe, Argentina
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Sarandi Buenos Aires, Argentina
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Villa Ballester, Argentina
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Ashford, Australia
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Fitzroy, Australia
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Frankston, Australia
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Garran, Australia
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Geelong, Australia
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Launceston, Australia
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Maroubra, Australia
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Milton, Australia
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Sherwood, Australia
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Southport, Australia
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Windsor, Australia
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Belem, Brazil
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Brasilia, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Goiânia, Brazil
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Marilia, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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Sao Paulo, Brazil
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São Paulo, Brazil
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
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Spruce Grove, Alberta, Canada
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British Columbia
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New Westminster, British Columbia, Canada
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Surrey, British Columbia, Canada
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Victoria, 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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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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Ontario
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Brampton, Ontario, Canada
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Courtice, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Scarborough, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Brossard, Quebec, Canada
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromee, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St-Lambert, Quebec, Canada
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Saskatchewan
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, Chile
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Temuco, Chile
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Beijing, China
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Changsha, China
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Guangzhou, China
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Hong Kong, China
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Nanjing, China
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Shanghai, China
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Suzhou, China
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Tianjin, China
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Beroun, Czech Republic
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Blansko, Czech Republic
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Breclav, Czech Republic
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Brno, Czech Republic
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Caslav, Czech Republic
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Cheb, Czech Republic
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Chrudim III, Czech Republic
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Havirov, Czech Republic
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Hodonin, Czech Republic
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Horovice, Czech Republic
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Hradec Kralove, Czech Republic
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Jablonec nad Nisou, Czech Republic
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Kromeriz, Czech Republic
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Olomouc-Lazce, Czech Republic
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Ostrava, Czech Republic
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Ostrava - Belsky les, Czech Republic
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Ostrava - Kuncice, Czech Republic
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Ostrava-Vitkovice, Czech Republic
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Pardubice, Czech Republic
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Plzen, Czech Republic
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Praha, Czech Republic
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Praha 2, Czech Republic
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Praha 6, Czech Republic
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Prelouc, Czech Republic
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Slany, Czech Republic
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Uherske Hradiste, Czech Republic
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Valaske Klobouky, Czech Republic
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Zlin, Czech Republic
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Amiens, France
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Bron, France
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Colmar Cedex, France
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Corbeil Essonnes, France
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Nantes cedex 1, France
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Paris Cedex 10, France
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Pessac, France
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Poitiers Cedex, France
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Reims Cedex, France
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Toulouse Cedex, France
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Aschaffenburg, Germany
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Bad Nauheim, Germany
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Bad Oeynhausen, Germany
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Berlin, Germany
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Deggingen, Germany
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Dippoldiswalde, Germany
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Dortmund, Germany
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Dresden, Germany
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Eschweiler, Germany
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Gießen, Germany
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Goch, Germany
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Gueglingen, Germany
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Hamburg, Germany
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Hohenmölsen, Germany
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Kassel, Germany
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Leipzig, Germany
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Mayen, Germany
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Rehlingen Siersburg, Germany
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Rotenburg, Germany
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Hong Kong, Hong Kong
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Shatin
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Hong Kong, Shatin, Hong Kong
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Balatonfüred, Hungary
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Budapest, Hungary
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Békéscsaba, Hungary
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Cegled, Hungary
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Csongrad, Hungary
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Eger, Hungary
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Gyor, Hungary
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Gyula, Hungary
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Gyöngyös, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Pecs, Hungary
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Siofok, Hungary
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Szolnok, Hungary
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Veszprém, Hungary
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Ahmedabad, India
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Bangalore, India
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Bengaluru, India
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Ernakulam District, India
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Hyderabad, India
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Indore, India
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Jaipur, India
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Mumbai, India
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Mysore, India
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Nagpur, India
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New Delhi, India
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Pune, India
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Vadodara, India
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Ashkelon, Israel
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Beer Sheva, Israel
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Dimona, Israel
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Givatayim, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar-Saba, Israel
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Nahariya, Israel
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Petach Tikva, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Tel-Aviv, Israel
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Zefat, Israel
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Zerifin, Israel
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Bergamo, Italy
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Catania, Italy
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Firenze, Italy
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Mercato San Severino, Italy
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Milano, Italy
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Napoli, Italy
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Negrar - VR, Italy
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Padova, Italy
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Parma, Italy
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Pavia, Italy
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Pozzuoli, Italy
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Prato, Italy
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Ravenna, Italy
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Roma, Italy
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Rozzano, Italy
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S Maria Capua Vetere, Italy
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San Giovanni Rotondo, Italy
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Sessa Aurunca, Italy
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Taormina, Italy
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Terni, Italy
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Aguascalientes, Mexico
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Culiacan, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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Mexico, Mexico
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Monclova, Mexico
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Monterrey, Mexico
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México, Mexico
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Nuevo Leon, Mexico
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Oaxaca, Mexico
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Queretaro, Mexico
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San Luis Potosi, Mexico
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San Luis Potosí, Mexico
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Tijuana, Mexico
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Xalapa, Mexico
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Almelo, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Apeldoorn, Netherlands
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Arnhem, Netherlands
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Breda, Netherlands
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Delft, Netherlands
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Eindhoven, Netherlands
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Goes, Netherlands
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Gouda, Netherlands
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Groningen, Netherlands
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Hardenberg, Netherlands
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Hoogeveen, Netherlands
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Hoorn, Netherlands
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Leiderdorp, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Sneek, Netherlands
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Utrecht, Netherlands
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Velp, Netherlands
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Waalwijk, Netherlands
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Zoetermeer, Netherlands
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Callao, Peru
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Lima, Peru
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San Isidro, Peru
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Bydgoszcz, Poland
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Gdansk, Poland
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Kamieniec Ząbkowicki, Poland
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Koluszki, Poland
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Krakow, Poland
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Lodz, Poland
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Mrgowo, Poland
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Nakso nad Noteci, Poland
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Opole, Poland
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Oława, Poland
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Poznan, Poland
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Przemyśl, Poland
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Sieradz, Poland
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Skierniewice, Poland
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Toruń, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Wrocław, Poland
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Wąbrzeźno, Poland
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Zabrze, Poland
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Łęczna, Poland
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Aguas Buneas, Puerto Rico
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Bayamon, Puerto Rico
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Cidra, Puerto Rico
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Hato Rey, Puerto Rico
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Jardines de Loiza, Loiza, Puerto Rico
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Juncos, Puerto Rico
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Ponce, Puerto Rico
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Rio Piedras, Puerto Rico
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San Juan, Puerto Rico
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Toa Baja, Puerto Rico
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Ekaterinburg, Russian Federation
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Kazan, Russian Federation
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Moscow, Russian Federation
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Novosibirsk, Russian Federation
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Saint Petersburg, Russian Federation
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Saint-Petersburg, Russian Federation
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Saratov, Russian Federation
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St. Petersburg, Russian Federation
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St.-Petersburg, Russian Federation
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St.Petersburg, Russian Federation
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StPetersburg, Russian Federation
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Benoni, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Parow, South Africa
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Pretoria, South Africa
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Umkomaas, South Africa
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Verulam, South Africa
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Alicante, Spain
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Barcelona, Spain
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Granada, Spain
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Jerez de la Frontera Cadiz, Spain
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Lérida, Spain
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Madrid, Spain
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Majadahonda, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Santiago de Compostela, Spain
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Sevilla, Spain
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Valencia, Spain
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Brämhult, Sweden
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Eksjö, Sweden
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Goteborg, Sweden
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Göteborg, Sweden
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Helsingborg, Sweden
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Jönköping, Sweden
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Malmo, Sweden
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Rättvik, Sweden
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Stockholm, Sweden
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Söråker, Sweden
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Umeå, Sweden
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Örebro, Sweden
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Östersund, Sweden
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Kaohsiung, Taiwan
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Kaohsiung Hsien, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Yong-Kang City, Taiwan
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Bangkok, Thailand
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Bangkoknoi, Thailand
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Chiang Mai, Thailand
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Khon Kaen, Thailand
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Ratchaburi, Thailand
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Aylesbury, United Kingdom
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Bath, United Kingdom
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Belfast, United Kingdom
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Blackpool, United Kingdom
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Corsham, United Kingdom
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Coventry, United Kingdom
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Fowey, United Kingdom
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Kenton, United Kingdom
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Leicester, United Kingdom
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Mortimer Reading, United Kingdom
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Plymouth, United Kingdom
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Sheffield, United Kingdom
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Sunbury on Thames, United Kingdom
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Swindon, United Kingdom
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Wansford, United Kingdom
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Warminster, United Kingdom
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Whitstable, United Kingdom
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Alabama
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Birmingham, Alabama, United States
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Arizona
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Little Rock, Arkansas, United States
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California
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Alhambra, California, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Burlingame, California, United States
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Duarte, California, United States
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Huntington Park, California, United States
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La Mesa, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Ramon, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Longmont, Colorado, United States
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Connecticut
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Bridgeport, Connecticut, United States
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Bristol, Connecticut, United States
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Southington, Connecticut, 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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Coral Springs, Florida, United States
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Daytona, Florida, United States
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Daytona Beach, Florida, United States
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Deerfield Beach, Florida, United States
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Ft Lauderdale, Florida, United States
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Green Cove Springs, Florida, United States
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Hialeah, Florida, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Oakland Park, Florida, United States
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Ocala, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pembroke Pines, Florida, United States
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Plant City, Florida, United States
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Sarasota, Florida, United States
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St Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Georgia
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Conyers, Georgia, United States
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Cumming, 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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Hayden Lake, Idaho, United States
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Pocatello, Idaho, United States
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Illinois
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Belleville, Illinois, United States
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Chicago, Illinois, United States
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Niles, Illinois, United States
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Indiana
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Fishers, Indiana, United States
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Fort Wayne, Indiana, United States
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Franklin, Indiana, United States
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Greenfield, Indiana, United States
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Valparaiso, Indiana, United States
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Iowa
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Council Bluffs, Iowa, United States
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Kansas
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Kentucky
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Evansville, Kentucky, United States
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Louisiana
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Kenner, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Maine
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Auburn, Maine, United States
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Bangor, Maine, United States
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Portland, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Towson, Maryland, United States
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Massachusetts
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Natick, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Michigan
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Alpena, Michigan, United States
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Cadillac, Michigan, United States
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Kalamazoo, Michigan, United States
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Petosky, Michigan, United States
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Pontiac, Michigan, United States
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Rochester, Michigan, United States
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Waterford, Michigan, United States
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Ypsilanti, Michigan, United States
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Minnesota
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Baxter, Minnesota, United States
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Chaska, Minnesota, United States
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Duluth, Minnesota, United States
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Eagan, Minnesota, United States
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Minneapolis, Minnesota, United States
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Robbinsdale, Minnesota, United States
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Missouri
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Kansas City, Missouri, United States
- Research Site
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St Louis, Missouri, United States
- Research Site
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St. Louis, Missouri, United States
- Research Site
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Montana
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Billings, Montana, United States
- Research Site
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Nebraska
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Bellevue, Nebraska, United States
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Fremont, Nebraska, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Nevada
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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New Jersey
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Elizabeth, New Jersey, United States
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Elmer, New Jersey, United States
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Voorhees, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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Binghamton, New York, United States
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Bronx, New York, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Endwell, New York, United States
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New Hyde Park, New York, United States
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Northport, New York, United States
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Saratoga Springs, New York, United States
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Syracuse, New York, United States
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Westfield, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Monroe, North Carolina, United States
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Morganton, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Smithfield, North Carolina, United States
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Winston-Salem, North Carolina, United States
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North Dakota
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Grand Forks, North Dakota, United States
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Ohio
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Beachwood, Ohio, United States
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Cadiz, Ohio, United States
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Canal Fulton, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Delaware, Ohio, United States
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Elyria, Ohio, United States
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Kettering, Ohio, United States
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Lorain, Ohio, United States
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Middleburg Hights, Ohio, United States
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Sandusky, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Altoona, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Clymer, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Hermitage, Pennsylvania, United States
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Indiana, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Tyrone, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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South Carolina
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Spartenburg, South Carolina, United States
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South Dakota
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Rapid City, South Dakota, United States
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Tennessee
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Bristol, Tennessee, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Amarillo, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Colleyville, Texas, United States
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Dallas, Texas, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Katy, Texas, United States
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MC Allen, Texas, United States
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Midland, Texas, United States
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Mission, Texas, United States
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Odessa, Texas, United States
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Plano, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Southlake, Texas, United States
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Tomball, Texas, United States
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Victoria, Texas, United States
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Virginia
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Burke, Virginia, United States
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Manassas, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Washington
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Burien, Washington, United States
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Federal Way, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with type 2 diabetes mellitus
- HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
- High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Exclusion Criteria:
- Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
- Acute vascular event <2months prior to randomisation
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
|
|
Experimental: Saxagliptin
|
5 mg or 2.5 mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Time Frame: Randomization (day 0) up to 2.9 years
|
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke.
If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
|
Randomization (day 0) up to 2.9 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation
Time Frame: Randomization (day 0) up to 2.9 years
|
Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation.
If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
|
Randomization (day 0) up to 2.9 years
|
|
Participants With Event of Death
Time Frame: Randomization (day 0) up to 2.9 years
|
Participants with event of death.
If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
|
Randomization (day 0) up to 2.9 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Eugene Braunwald, TIMI
- Principal Investigator: Itamar Raz, Hadassah Medical Organization
- Principal Investigator: Deepak Bhatt, TIMI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
- Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.
- Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.
- Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.
- Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.
- Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.
- Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.
- Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.
- Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.
- Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.
- Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.
- Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum In: Circulation. 2015 Oct 13;132(15):e198.
- Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.
- Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.
- Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.
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
May 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 25, 2010
First Submitted That Met QC Criteria
April 20, 2010
First Posted (Estimate)
April 21, 2010
Study Record Updates
Last Update Posted (Estimate)
July 17, 2014
Last Update Submitted That Met QC Criteria
July 9, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Saxagliptin
Other Study ID Numbers
- D1680C00003
- EudraCT No 2009-017358-10
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.