- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730534
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)
December 11, 2019 updated by: AstraZeneca
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17190
Phase
- Phase 3
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, C1425AGC
- Research Site
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Buenos Aires, Argentina, 1205
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Caba, Argentina, C1093AAS
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Ciudad Autonoma Buenos Aires, Argentina, C1181ACH
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Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
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Cordoba, Argentina, 5000
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Cordoba, Argentina, X5006CBI
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Cordoba, Argentina, X5008HHW
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La Plata, Argentina, 1900
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La Plata, Argentina, B1902COS
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Lanus, Argentina, B1824KAJ
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Mar del Plata, Argentina, 7600
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Mar del Plata, Argentina, B7600FZN
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Ramos Mejía, Argentina, B1704ETD
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Rosario, Argentina, S2000DNM
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Rosario, Argentina, S2000CVD
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San Nicolás, Argentina, B2900DMH
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Santa Fe, Argentina, S3000FWO
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Adelaide - Oaklands Park, Australia, 5046
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Ashford, Australia, 5035
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Box Hill, Australia, 3128
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Camperdown, Australia, 2050
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Darlinghurst, Australia, 2010
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Fullarton, Australia, 5063
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Garran, Australia, 2605
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Geelong, Australia, 3220
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Heidelberg West, Australia, 3081
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Herston, Australia, 4029
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Joondalup, Australia, 6027
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Maroubra, Australia, 2035
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Melbourne, Australia, 3004
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Milton, Australia, 4064
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Murdoch, Australia, 6150
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Wollongong, Australia, 2500
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2060
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Bonheiden, Belgium, 2820
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Brasschaat, Belgium, 2930
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Brugge, Belgium, 8000
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Brussels, Belgium, 1070
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Mechelen, Belgium, 2800
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Merksem, Belgium, 2170
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Roeselare, Belgium, 8800
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Tienen, Belgium, 3300
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Turnhout, Belgium, 2300
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Belo Horizonte, Brazil, 30150-240
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Brasilia, Brazil, 71625-175
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Campina Grande do Sul, Brazil, 83430000
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Campinas, Brazil, 13060-904
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Campinas, Brazil, 13010-001
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Marilia, Brazil, 17515-000
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Porto Alegre, Brazil, 90035-003
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Sao Jose dos Campos, Brazil, 12243-280
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Sao Paulo, Brazil, 01228-200
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São José do Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 05403-000
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São Paulo, Brazil, 01228-000
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Blagoevgrad, Bulgaria, 2700
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Botevgrad, Bulgaria, 2140
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Dimitrovgrad, Bulgaria, 6400
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Dupnitsa, Bulgaria, 2600
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Gotse Delchev, Bulgaria, 2900
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Kozloduy, Bulgaria, 3320
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Kyustendil, Bulgaria, 2500
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Lukovit, Bulgaria, 5770
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Petrich, Bulgaria, 2900
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4000
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Russe, Bulgaria, 7002
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Sandanski, Bulgaria, 2800
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Sevlievo, Bulgaria, 5400
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Sliven, Bulgaria, 8800
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Smolyan, Bulgaria, 4700
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Sofia, Bulgaria
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1202
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1303
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Sofia, Bulgaria, 1324
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Sofia, Bulgaria, 1223
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Sofia, Bulgaria, 1632
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Stara Zagora, Bulgaria, 6000
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Yambol, Bulgaria, 8600
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Laval, Canada, H7M3L9
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Quebec, Canada, G1G 3Y8
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Quebec, Canada, G1V 4G5
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Quebec, Canada, G1N 4V3
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Quebec, Canada, G1V 4G2
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Alberta
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Calgary, Alberta, Canada, T2H 2G4
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Calgary, Alberta, Canada, T2T 5C7
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W5
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Surrey, British Columbia, Canada, V3V 0C6
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
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Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Sydney Mines, Nova Scotia, Canada, B1V 2L2
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Ontario
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Brampton, Ontario, Canada, L6Z 4N5
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Brampton, Ontario, Canada, L6S 0C6
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Brampton, Ontario, Canada, L6W 2X7
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Cambridge, Ontario, Canada, N1R 6V6
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Cambridge, Ontario, Canada, N1R 7L6
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Concord, Ontario, Canada, L4K 4M2
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London, Ontario, Canada, N5W 6A2
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London, Ontario, Canada, N6A 5A5
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London, Ontario, Canada, N6A 4V2
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London, Ontario, Canada, N6G 2M1
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North York, Ontario, Canada, M3J 1N2
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Oakville, Ontario, Canada, L6M 1M1
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Oshawa, Ontario, Canada, L1J 2K1
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Scarborough, Ontario, Canada, M1E 5E9
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Smiths Falls, Ontario, Canada, K7A 4W8
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M4G 3E8
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Toronto, Ontario, Canada, M5T 3L9
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
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Laval, Quebec, Canada, H7T 2P5
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Levis, Quebec, Canada, G6V 4Z5
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Longueuil, Quebec, Canada, J4M 2X1
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Montreal, Quebec, Canada, H4A 3J1
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Montreal, Quebec, Canada, H1M 1B1
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Montreal, Quebec, Canada, H2W 1R7
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Montréal, Quebec, Canada, H1T 1C8
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Pointe-Claire, Quebec, Canada, H9R 3J1
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Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
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Saint-Georges, Quebec, Canada, G5Y 4T8
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Sherbrooke, Quebec, Canada, J1H 5N4
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Sherbrooke, Quebec, Canada, J1G 5K2
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Sherbrooke, Quebec, Canada, J1J 2E3
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Terrebonne, Quebec, Canada, J6V 2H2
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Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
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Saskatoon, Saskatchewan, Canada, S7H 5M3
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Beijing, China, 100044
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Beijing, China, 100096
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Changsha, China, 410011
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Guangzhou, China, 510080
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Guangzhou, China, 510630
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Hefei, China, 230022
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Jinan, China, 250013
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Nanchang, China, 330006
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Nanjing, China, 210012
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Shanghai, China, 200065
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ShiJiazhuang, China, 050051
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Tianjin, China, 300211
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Beroun, Czechia, 266 01
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Brno, Czechia, 656 91
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Brno, Czechia, 615 00
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Brno, Czechia, 603 00
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Brno, Czechia, 62500
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Cheb, Czechia, 350 02
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Chomutov, Czechia, 430 02
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Chrudim III, Czechia, 537 01
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Hodonin, Czechia, 695 01
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Horovice, Czechia, 268 01
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Hradec Kralove, Czechia, 500 05
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Jilove u Prahy, Czechia, 254 01
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Kromeriz, Czechia, 767 01
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Ostrava - Belsky les, Czechia, 700 30
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Ostrava - Dubina, Czechia, 700 30
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Ostrava - Kuncice, Czechia, 707 02
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Ostrava-Moravska, Czechia, 702 00
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Plzen, Czechia, 30100
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Plzen - Severni Predmesti, Czechia, 301 00
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Praha, Czechia, 152 00
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Praha 4, Czechia, 140 46
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Praha 5, Czechia, 154 00
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Praha 6, Czechia, 163 00
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Prelouc, Czechia, 535 01
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Rakovnik, Czechia, 269 01
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Slany, Czechia, 274 01
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Teplice, Czechia, 415 01
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Uherske Hradiste, Czechia, 686 01
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Usti nad Labem, Czechia, 400 01
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Zlin, Czechia, 760 01
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Angers cedex 9, France, 49033
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Corbeil-Essonnes, France, 91100
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Dijon, France, 21079
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Dijon Cedex, France, 21079
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La Rochelle, France, 17019
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Le Creusot, France, 71206
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Nantes Cedex 1, France, 44093
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Nantes Cedex 2, France, 44277
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Pessac, France, 33604
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Poitiers Cedex, France, 86021
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TOULOUSE Cedex 9, France, 31059
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Aschaffenburg, Germany, 63739
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Bad Mergentheim, Germany, 97980
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Bad Oeynhausen, Germany, 32545
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Berlin, Germany, 10115
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Berlin, Germany, 13347
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Berlin, Germany, 12559
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Dippoldiswalde, Germany, 01744
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Freiburg, Germany, 79106
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Hamburg, Germany, 22391
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Kassel, Germany, 34121
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Köln, Germany, 51069
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Leipzig, Germany, 04103
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München, Germany, 80333
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Villingen-Schwenningen, Germany, 78048
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Causeway Bay, Hong Kong
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Hongkong, Hong Kong
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Tai Po, Hong Kong
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Balatonfüred, Hungary, 8230
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Ballasagyarmat, Hungary, 2660
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Berettyóújfalu, Hungary, 4100
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Budapest, Hungary, 1125
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Budapest, Hungary, 1135
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Budapest, Hungary, 1096
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Budapest, Hungary, 1106
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Budapest, Hungary, 1171
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Budapest, Hungary, 1032
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Budapest, Hungary, 1212
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Cegléd, Hungary, 2700
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Csongrád, Hungary, 6640
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Debrecen, Hungary, 4032
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Debrecen, Hungary, 4025
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Debrecen, Hungary, 4031
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Eger, Hungary, 3300
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Esztergom, Hungary, 2500
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Gyor, Hungary, 9024
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Gyöngyös, Hungary, 3200
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Kecskemét, Hungary, 6000
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Kistarcsa, Hungary, 2143
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Komárom, Hungary, 2921
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Mórahalom, Hungary, 6782
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Nyíregyháza, Hungary, 4400
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Polgár, Hungary, 4090
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Sopron, Hungary, 9400
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Szolnok, Hungary, 5004
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Székesfehérvár, Hungary, 8000
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Tát, Hungary, 2534
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Zalaegerszeg, Hungary, 8900
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Ács, Hungary, 2941
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Ahmedabad, India, 380060
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Bangalore, India, 560002
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Bangalore, India, 560034
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Pune, India, 411 011
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Vellore, India, 632004
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Afula, Israel, 18101
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Ashkelon, Israel, 78278
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Beer Sheva, Israel, 84350
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Bnei Barak, Israel, 5136166
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Hadera, Israel, 38100
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Haifa, Israel, 34362
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Haifa, Israel, 31096
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Haifa, Israel, 35152
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Holon, Israel, 58100
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Jerusalem, Israel, 91120
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Jerusalem, Israel, 93106
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Naharia, Israel, 22100
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Petach Tikva, Israel, 49100
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Bergamo, Italy, 24100
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Firenze, Italy, 50141
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Milano, Italy, 20132
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Milano, Italy, 20162
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Milano, Italy, 20138
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Napoli, Italy, 80131
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Negrar - VR, Italy, 37024
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Padova, Italy, 35128
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Parma, Italy, 43100
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Pavia, Italy, 27100
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Rozzano, Italy, 20089
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S Maria Capua Vetere, Italy, 81055
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Sessa Aurunca, Italy, 81037
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Verona, Italy, 37126
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Bunkyo-ku, Japan, 113-8655
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Daito-shi, Japan, 574-0074
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Kasuga-shi, Japan, 816-0864
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Kobe-shi, Japan, 655-0017
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Kumamoto-shi, Japan, 860-8556
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Matsubara-shi, Japan, 580-0032
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Saga-shi, Japan, 849-8501
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Ube-shi, Japan, 755-8505
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Uji-shi, Japan, 611-0041
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Yao-shi, Japan, 581-0011
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Yokohama-shi, Japan, 236-0004
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Bucheon-si, Korea, Republic of, 420-717
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Busan, Korea, Republic of, 47392
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Cheongju-si, Korea, Republic of, 28644
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Daegu, Korea, Republic of, 705-718
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Daejeon, Korea, Republic of, 301721
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Goyang-si, Korea, Republic of, 10444
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Gyeonggi-do, Korea, Republic of, 11923
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Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-71
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Jung-gu, Korea, Republic of, 41944
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 02841
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Seoul, Korea, Republic of, 06591
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Seoul, Korea, Republic of, 110746
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Seoul, Korea, Republic of, 135710
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Suwon-si, Korea, Republic of, 16499
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Uijeongbu-si, Korea, Republic of, 480717
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Acapulco, Mexico, 39670
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Culiacan, Mexico, 80230
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Del. Cuauhtemoc, Mexico, 06700
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Distrito Federal, Mexico, 07760
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Distrito Federal, Mexico, 14000
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Guadalajara, Mexico, 44670
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Guadalajara, Mexico, 44150
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Guadalajara, Mexico, 44160
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Guadalajara, Mexico, 44600
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Meridas, Mexico, 97070
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Mexico, Mexico, 11560
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Mexico, Mexico, 11850
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Monterey, Mexico, 64060
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Monterrey, Mexico, 64460
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Monterrey, Mexico, 64465
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Pachuca de Soto, Mexico, 42090
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Queretaro, Mexico, 76000
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San Luis Potosi, Mexico, 78200
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Tijuana, Mexico, 22210
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Veracruz, Mexico, 91900
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Xalapa, Mexico, 91193
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Zapopan, Mexico, 45116
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Zapopan, Jalisco, Mexico, 45200
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Alkmaar, Netherlands, 1815JD
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Amsterdam, Netherlands, 1105 AZ
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Apeldoorn, Netherlands, 7334 DZ
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Arnhem, Netherlands, 6815 AD
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Breda, Netherlands, 4818 CK
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Delft, Netherlands, 2625 AD
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Den Haag, Netherlands, 2597 AX
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EDE, Netherlands, 6716 RP
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Eindhoven, Netherlands, 5631 BM
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Gouda, Netherlands, 2803 HH
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Groningen, Netherlands, 9728 NT
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Haarlem, Netherlands, 2035 RC
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Hardenberg, Netherlands, 7772 SE
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Heerlen, Netherlands, 6419 PC
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Hoogeveen, Netherlands, 7909 AA
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Nijmegen, Netherlands, 6532 SZ
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Rotterdam, Netherlands, 3045 PM
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Rotterdam, Netherlands, 3039 BD
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Sliedrecht, Netherlands, 3361 XV
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Sneek, Netherlands, 8601 ZR
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Utrecht, Netherlands, 3584 CX
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Venlo, Netherlands, 5912 BL
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Zutphen, Netherlands, 7207 AE
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Bacolod, Philippines, 6100
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Cebu City, Philippines, 6000
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Dasmarinas City, Philippines, 4114
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Iloilo City, Philippines, 5000
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Lipa City, Philippines, 4217
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Makati City, Philippines, 1218
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Mandaluyong City, Philippines, 1554
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Manila, Philippines, 1000
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Manila, Philippines, 1003
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Manila, Philippines, 1008
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Marikina City, Philippines, 1810
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Pasay City, Philippines, 1300
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Pasig City, Philippines, 1605
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Quezon City, Philippines, 1104
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Quezon City, Philippines, 1101
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Quezon City, Philippines, 1112
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Quezon City, Philippines, 1100
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Tanauan City, Philippines, 4232
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Biała Rawska, Poland, 96-230
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Bydgoszcz, Poland, 85-681
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ChrzanÓw, Poland, 32-500
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Gdansk, Poland, 80-858
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Gdańsk, Poland, 80-952
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Gdynia, Poland, 81-423
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Giżycko, Poland, 11-500
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Katowice, Poland, 40-081
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Koluszki, Poland, 95-040
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Krakow, Poland, 31-121
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Kraków, Poland, 31-156
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Legnica, Poland, 59-220
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Lublin, Poland, 20-044
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Mrągowo, Poland, 11-700
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Nakło nad Notecią, Poland, 89-100
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Poznan, Poland, 61655
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Poznan, Poland, 61-289
- Research Site
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Płock, Poland, 09-402
- Research Site
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Ruda Śląska, Poland, 41-709
- Research Site
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Skierniewice, Poland, 96-100
- Research Site
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Sobótka, Poland, 55-050
- Research Site
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Sokółka, Poland, 16-100
- Research Site
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Torun, Poland, 87-100
- Research Site
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Toruń, Poland, 87-100
- Research Site
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Warszawa, Poland, 02-679
- Research Site
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Warszawa, Poland, 03-973
- Research Site
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Wierzchosławice, Poland, 33-122
- Research Site
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Wrocław, Poland, 50-403
- Research Site
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Wrocław, Poland, 50-981
- Research Site
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Węgrów, Poland, 07-100
- Research Site
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Włocławek, Poland, 87-800
- Research Site
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Zabrze, Poland, 41-800
- Research Site
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Łęczna, Poland, 21-010
- Research Site
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-
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Bacau, Romania, 600114
- Research Site
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Bacau, Romania, 600164
- Research Site
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Bucharest, Romania, 010507
- Research Site
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Bucharest, Romania, 020475
- Research Site
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Bucharest, Romania, 020614
- Research Site
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Bucuresti, Romania, 020359
- Research Site
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Bucuresti, Romania, 011234
- Research Site
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Bucuresti, Romania, 020042
- Research Site
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Bucuresti, Romania, 20048
- Research Site
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Cluj Napoca, Romania, 400006
- Research Site
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Cluj Napoca, Romania, 400353
- Research Site
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Constanta, Romania, 900675
- Research Site
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Galati, Romania, 800371
- Research Site
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Iasi, Romania, 700732
- Research Site
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Iasi, Romania, 700400
- Research Site
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Iasi, Romania, 700515
- Research Site
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Iasi, Romania, 700613
- Research Site
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Ploiesti, Romania, 100163
- Research Site
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Sibiu, Romania, 550371
- Research Site
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Timisoara, Romania, 300125
- Research Site
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Tirgu Mures, Romania, 540013
- Research Site
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Târgu Mures, Romania, 540136
- Research Site
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Zalau, Romania, 450129
- Research Site
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-
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Arkhangelsk, Russian Federation, 163001
- Research Site
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Chelyabinsk, Russian Federation, 454106
- Research Site
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Chelyabinsk, Russian Federation, 454091
- Research Site
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Ivanovo, Russian Federation, 153012
- Research Site
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Izhevsk, Russian Federation, 426063
- Research Site
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Kazan, Russian Federation, 420012
- Research Site
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Kazan, Russian Federation, 420029
- Research Site
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Moscow, Russian Federation, 125367
- Research Site
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Moscow, Russian Federation, 121552
- Research Site
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Moscow, Russian Federation, 127473
- Research Site
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Moscow, Russian Federation, 129301
- Research Site
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Moscow, Russian Federation, 117292
- Research Site
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Moscow, Russian Federation, 119034
- Research Site
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Moscow, Russian Federation, 129110
- Research Site
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Nizhnii Novgorod, Russian Federation, 603018
- Research Site
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Novosibirsk, Russian Federation, 630008
- Research Site
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Perm, Russian Federation, 6144090
- Research Site
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Rostov-on-Don, Russian Federation, 344022
- Research Site
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Saint Petersburg, Russian Federation, 194044
- Research Site
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Saint Petersburg, Russian Federation, 194354
- Research Site
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Saint Petersburg, Russian Federation, 193312
- Research Site
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Saint Petersburg, Russian Federation, 195257
- Research Site
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Saint Petersburg, Russian Federation, 198217
- Research Site
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Saint Petersburg, Russian Federation, 198328
- Research Site
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Saint- Petersburg, Russian Federation, 192148
- Research Site
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Saint-Petersburg, Russian Federation, 199106
- Research Site
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Saratov, Russian Federation, 410053
- Research Site
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Tver, Russian Federation, 170036
- Research Site
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Ufa, Russian Federation, 450071
- Research Site
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Vladikavkaz, Russian Federation, 362027
- Research Site
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Volgograd, Russian Federation, 400005
- Research Site
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Yekaterinburg, Russian Federation, 620039
- Research Site
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-
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-
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Banská Bystrica, Slovakia, 97401
- Research Site
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Bratislava, Slovakia, 81108
- Research Site
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Bratislava, Slovakia, 83301
- Research Site
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Dolný Kubín, Slovakia, 02601
- Research Site
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Kosice, Slovakia, 04011
- Research Site
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Kosice, Slovakia, 04022
- Research Site
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Košice, Slovakia, 04001
- Research Site
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Levice, Slovakia, 934 01
- Research Site
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Lučenec, Slovakia, 98401
- Research Site
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Nove Zamky, Slovakia, 94001
- Research Site
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Námestovo, Slovakia, 02901
- Research Site
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Piešťany, Slovakia, 92101
- Research Site
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Poprad, Slovakia, 058 01
- Research Site
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Povazska Bystrica, Slovakia, 01701
- Research Site
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Prievidza, Slovakia, 97101
- Research Site
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Rimavská Sobota, Slovakia, 97901
- Research Site
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Sabinov, Slovakia, 083 01
- Research Site
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Sala, Slovakia, 927 01
- Research Site
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Trebišov, Slovakia, 07501
- Research Site
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Trenčín, Slovakia, 91101
- Research Site
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Vrutky, Slovakia, 038 61
- Research Site
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Žilina, Slovakia, 01001
- Research Site
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-
-
-
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Alberton, South Africa, 1450
- Research Site
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Benoni, South Africa, 1500
- Research Site
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Cape Town, South Africa, 7505
- Research Site
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Cape Town, South Africa, 7500
- Research Site
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Cape Town, South Africa, 7405
- Research Site
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Diepkloof, Soweto, South Africa, 2013
- Research Site
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Durban, South Africa, 4001
- Research Site
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Durban, South Africa, 4052
- Research Site
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Goodwood, South Africa, 7460
- Research Site
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Houghton, South Africa, 2198
- Research Site
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Muckleneuk, South Africa, 0002
- Research Site
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Parktown, South Africa, 2193
- Research Site
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Parktown West, South Africa, 2193
- Research Site
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Phoenix, South Africa, 4068
- Research Site
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Somerset West, South Africa, 7130
- Research Site
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Verulam, South Africa, 4345
- Research Site
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Worcester, South Africa, 6850
- Research Site
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-
-
-
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Almeria, Spain, 04120
- Research Site
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Barcelona, Spain, 08041
- Research Site
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Barcelona, Spain, 08003
- Research Site
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L'Hospitalet de Llobregat, Spain, 08907
- Research Site
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Madrid, Spain, 28046
- Research Site
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Madrid, Spain, 28049
- Research Site
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Oviedo, Spain, 33011
- Research Site
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Sant Joan Despi, Spain, 08970
- Research Site
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Santiago de Compostela, Spain, 15706
- Research Site
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Sevilla, Spain, 41071
- Research Site
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-
-
-
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Borås, Sweden, 506 30
- Research Site
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Eksjö, Sweden, 57535
- Research Site
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Finspång, Sweden, 612 37
- Research Site
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Gothenburg, Sweden, 41345
- Research Site
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Gothenburg, Sweden, 41685
- Research Site
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Järfälla, Sweden, 177 30
- Research Site
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Linköping, Sweden, 589 29
- Research Site
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Lund, Sweden, 222 21
- Research Site
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Malmo, Sweden, 21152
- Research Site
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Ostersund, Sweden, 831 83
- Research Site
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Rättvik, Sweden, 79530
- Research Site
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Stockholm, Sweden, 171 76
- Research Site
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Stockholm, Sweden, 111 57
- Research Site
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Stockholm, Sweden, 117 28
- Research Site
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Umeå, Sweden, 907 36
- Research Site
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Vällingby, Sweden, 162 68
- Research Site
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-
-
-
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Changhua, Taiwan, 50006
- Research Site
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Kaohsiung, Taiwan, 80756
- Research Site
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Kaohsiung City, Taiwan, 83301
- Research Site
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Taichung, Taiwan, 40705
- Research Site
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Taichung City, Taiwan, 40201
- Research Site
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Taipei, Taiwan, 11217
- Research Site
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-
-
-
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Bangkok, Thailand, 10330
- Research Site
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Bangkok, Thailand, 10400
- Research Site
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Bangkok, Thailand, 10700
- Research Site
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Chiang Mai, Thailand, 50200
- Research Site
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Muang, Thailand, 40002
- Research Site
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Nakhon Ratchasima, Thailand, 30000
- Research Site
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Pathumthani, Thailand, 12120
- Research Site
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Phisanulok, Thailand, 65000
- Research Site
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Rajthevi, Thailand, 10400
- Research Site
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Ratchaburi, Thailand, 70000
- Research Site
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Ratchathewi, Thailand, 10400
- Research Site
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-
-
-
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Antalya, Turkey, 07058
- Research Site
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Istanbul, Turkey, 34093
- Research Site
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Istanbul, Turkey, 34865
- Research Site
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Istanbul, Turkey, 34360
- Research Site
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Istanbul, Turkey, 34730
- Research Site
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Izmir, Turkey, 35100
- Research Site
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İzmir, Turkey, 35210
- Research Site
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-
-
-
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Dnepropetrovsk, Ukraine, 49006
- Research Site
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Dnipropetrovsk, Ukraine, 49038
- Research Site
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Donetsk, Ukraine, 83003
- Research Site
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Kharkiv, Ukraine, 61176
- Research Site
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Kharkov, Ukraine, 61018
- Research Site
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Kiev, Ukraine, 02176
- Research Site
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Kiev, Ukraine, 03015
- Research Site
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Kyiv, Ukraine, 01601
- Research Site
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Kyiv, Ukraine, 04114
- Research Site
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Vinnytsia, Ukraine, 21001
- Research Site
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Vynnitsa, Ukraine, 21018
- Research Site
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Zaporizhzhya, Ukraine, 69118
- Research Site
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Zaporozhye, Ukraine, 69001
- Research Site
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-
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Addlestone, United Kingdom, KT15 2BH
- Research Site
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Aylesbury, United Kingdom, HP22 5LB
- Research Site
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Bath, United Kingdom, BA3 2UH
- Research Site
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Belfast, United Kingdom, BT13 3BW
- Research Site
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Belfast, United Kingdom, BT7 2EB
- Research Site
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Blackpool, United Kingdom, FY4 3AD
- Research Site
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Canterbury, United Kingdom, CT1 3HX
- Research Site
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Corsham, United Kingdom, SN13 9DL
- Research Site
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Coventry, United Kingdom, CV6 4DD
- Research Site
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Glasgow, United Kingdom, G69 7AD
- Research Site
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Irvine, United Kingdom, KA12 0AY
- Research Site
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Leicester, United Kingdom, LE10 2SE
- Research Site
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Mortimer Reading, United Kingdom, RG7 3SQ
- Research Site
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Sheffield, United Kingdom, S35 9XQ
- Research Site
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Whitstable, United Kingdom, CT5 3SE
- Research Site
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-
-
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Alabama
-
Alexander City, Alabama, United States, 35010
- Research Site
-
Athens, Alabama, United States, 35611
- Research Site
-
Birmingham, Alabama, United States, 35294
- Research Site
-
Birmingham, Alabama, United States, 35243
- Research Site
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Mobile, Alabama, United States, 36608
- Research Site
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Montgomery, Alabama, United States, 36106
- Research Site
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-
Arizona
-
Mesa, Arizona, United States, 85206
- Research Site
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Mesa, Arizona, United States, 85213
- Research Site
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Phoenix, Arizona, United States, 85018
- Research Site
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California
-
Alhambra, California, United States, 91801
- Research Site
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Bakersfield, California, United States, 93308
- Research Site
-
Greenbrae, California, United States, 94904
- Research Site
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Huntington Park, California, United States, 90255
- Research Site
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La Mesa, California, United States, 91942
- Research Site
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Lomita, California, United States, 90717
- Research Site
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Los Alamitos, California, United States, 90720
- Research Site
-
Los Angeles, California, United States, 90022
- Research Site
-
Los Angeles, California, United States, 90067
- Research Site
-
Newport Beach, California, United States, 92663
- Research Site
-
San Diego, California, United States, 92103
- Research Site
-
San Marino, California, United States, 91108
- Research Site
-
San Ramon, California, United States, 94582
- Research Site
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Torrance, California, United States, 90502
- Research Site
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Ventura, California, United States, 93003
- Research Site
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Vista, California, United States, 92083
- Research Site
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Colorado
-
Fort Collins, Colorado, United States, 80528
- Research Site
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Golden, Colorado, United States, 80401
- Research Site
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Connecticut
-
Bridgeport, Connecticut, United States, 06610
- Research Site
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Bristol, Connecticut, United States, 06010
- Research Site
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Norwalk, Connecticut, United States, 06851
- Research Site
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Stamford, Connecticut, United States, 06905
- Research Site
-
Trumbull, Connecticut, United States, 06611
- Research Site
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Waterbury, Connecticut, United States, 06708
- Research Site
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-
Delaware
-
Newark, Delaware, United States, 19713
- Research Site
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Seaford, Delaware, United States, 19973
- Research Site
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Wilmington, Delaware, United States, 19803
- Research Site
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District of Columbia
-
Washington, District of Columbia, United States, 20037
- Research Site
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-
Florida
-
Bradenton, Florida, United States, 34201
- Research Site
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Chiefland, Florida, United States, 32626
- Research Site
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Clearwater, Florida, United States, 33756
- Research Site
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Coral Springs, Florida, United States, 33065
- Research Site
-
Daytona Beach, Florida, United States, 32117
- Research Site
-
Fort Lauderdale, Florida, United States, 33308
- Research Site
-
Fort Lauderdale, Florida, United States, 33312
- Research Site
-
Green Cove Springs, Florida, United States, 32043
- Research Site
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Hollywood, Florida, United States, 33021
- Research Site
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Jacksonville, Florida, United States, 32258
- Research Site
-
Jacksonville Beach, Florida, United States, 32250
- Research Site
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Lake Worth, Florida, United States, 33461
- Research Site
-
Lakeland, Florida, United States, 33805
- Research Site
-
Largo, Florida, United States, 33770
- Research Site
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Miami, Florida, United States, 33126
- Research Site
-
Miami, Florida, United States, 33186
- Research Site
-
Miami, Florida, United States, 33175
- Research Site
-
Miami, Florida, United States, 33144
- Research Site
-
Miami, Florida, United States, 33125
- Research Site
-
Miami, Florida, United States, 33155
- Research Site
-
Miami Beach, Florida, United States, 33140
- Research Site
-
Naples, Florida, United States, 34102
- Research Site
-
New Port Richey, Florida, United States, 34653
- Research Site
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Ocala, Florida, United States, 34471
- Research Site
-
Palm Beach Gardens, Florida, United States, 33410
- Research Site
-
Pembroke Pines, Florida, United States, 33029
- Research Site
-
Pembroke Pines, Florida, United States, 33025
- Research Site
-
Pensacola, Florida, United States, 32501
- Research Site
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Saint Petersburg, Florida, United States, 33713
- Research Site
-
Saint Petersburg, Florida, United States, 33709
- Research Site
-
Spring Hill, Florida, United States, 34609
- Research Site
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Stuart, Florida, United States, 34996
- Research Site
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Tampa, Florida, United States, 33634
- Research Site
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Trinity, Florida, United States, 34655
- Research Site
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Vero Beach, Florida, United States, 32960
- Research Site
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Wellington, Florida, United States, 33449
- Research Site
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-
Georgia
-
Atlanta, Georgia, United States, 30308
- Research Site
-
Calhoun, Georgia, United States, 30701
- Research Site
-
Cumming, Georgia, United States, 30041
- Research Site
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Savannah, Georgia, United States, 31406
- Research Site
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-
Hawaii
-
Honolulu, Hawaii, United States, 96814
- Research Site
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-
Idaho
-
Coeur d'Alene, Idaho, United States, 83814
- Research Site
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Research Site
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Chicago, Illinois, United States, 60611
- Research Site
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Chicago, Illinois, United States, 60607
- Research Site
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Rock Island, Illinois, United States, 61201
- Research Site
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-
Indiana
-
Anderson, Indiana, United States, 46011
- Research Site
-
Avon, Indiana, United States, 46123
- Research Site
-
Bloomington, Indiana, United States, 47403
- Research Site
-
Evansville, Indiana, United States, 47715
- Research Site
-
Evansville, Indiana, United States, 47713
- Research Site
-
Evansville, Indiana, United States, 47725
- Research Site
-
Greenfield, Indiana, United States, 46140
- Research Site
-
Muncie, Indiana, United States, 47304
- Research Site
-
Newburgh, Indiana, United States, 47630
- Research Site
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Research Site
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Research Site
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-
Kentucky
-
Louisville, Kentucky, United States, 40205
- Research Site
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-
Louisiana
-
Alexandria, Louisiana, United States, 71301
- Research Site
-
Hammond, Louisiana, United States, 70403
- Research Site
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Shreveport, Louisiana, United States, 71103
- Research Site
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Slidell, Louisiana, United States, 70458
- Research Site
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-
Maine
-
Auburn, Maine, United States, 04210
- Research Site
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Bangor, Maine, United States, 04401
- Research Site
-
Biddeford, Maine, United States, 04005
- Research Site
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Portland, Maine, United States, 04101
- Research Site
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-
Maryland
-
Baltimore, Maryland, United States, 21229
- Research Site
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Baltimore, Maryland, United States, 21218
- Research Site
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Beltsville, Maryland, United States, 20705
- Research Site
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Columbia, Maryland, United States, 21044
- Research Site
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-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Research Site
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Fall River, Massachusetts, United States, 02720
- Research Site
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Haverhill, Massachusetts, United States, 01830
- Research Site
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Methuen, Massachusetts, United States, 01844
- Research Site
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Natick, Massachusetts, United States, 01760
- Research Site
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-
Michigan
-
Alpena, Michigan, United States, 49707
- Research Site
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Flint, Michigan, United States, 48504
- Research Site
-
Flint, Michigan, United States, 48532
- Research Site
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Grand Blanc, Michigan, United States, 48439
- Research Site
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Jackson, Michigan, United States, 49201
- Research Site
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Kalamazoo, Michigan, United States, 49009
- Research Site
-
Petoskey, Michigan, United States, 49770
- Research Site
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Troy, Michigan, United States, 48085
- Research Site
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-
Minnesota
-
Duluth, Minnesota, United States, 55805
- Research Site
-
Eagan, Minnesota, United States, 55123
- Research Site
-
Saint Cloud, Minnesota, United States, 56303
- Research Site
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Research Site
-
Lee's Summit, Missouri, United States, 64064
- Research Site
-
Saint Louis, Missouri, United States, 63117
- Research Site
-
-
Montana
-
Billings, Montana, United States, 59102
- Research Site
-
Great Falls, Montana, United States, 59405
- Research Site
-
Kalispell, Montana, United States, 59901
- Research Site
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Research Site
-
Lincoln, Nebraska, United States, 68526
- Research Site
-
Omaha, Nebraska, United States, 68105
- Research Site
-
Omaha, Nebraska, United States, 68124
- Research Site
-
-
Nevada
-
Reno, Nevada, United States, 89502
- Research Site
-
-
New Jersey
-
Edison, New Jersey, United States, 08837
- Research Site
-
Newark, New Jersey, United States, 07103
- Research Site
-
Somerset, New Jersey, United States, 08873
- Research Site
-
Voorhees, New Jersey, United States, 08043
- Research Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Research Site
-
-
New York
-
Buffalo, New York, United States, 14215
- Research Site
-
New Hyde Park, New York, United States, 11042
- Research Site
-
New York, New York, United States, 10036
- Research Site
-
Northport, New York, United States, 11768
- Research Site
-
Poughkeepsie, New York, United States, 12601
- Research Site
-
Southampton, New York, United States, 11968
- Research Site
-
Stony Brook, New York, United States, 11794
- Research Site
-
Westfield, New York, United States, 14787
- Research Site
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- Research Site
-
Burlington, North Carolina, United States, 27215
- Research Site
-
Charlotte, North Carolina, United States, 28209
- Research Site
-
Hickory, North Carolina, United States, 28601
- Research Site
-
Lenoir, North Carolina, United States, 28645
- Research Site
-
Monroe, North Carolina, United States, 28110
- Research Site
-
Rocky Mount, North Carolina, United States, 27804
- Research Site
-
Salisbury, North Carolina, United States, 28144
- Research Site
-
Winston-Salem, North Carolina, United States, 27103
- Research Site
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Research Site
-
Fargo, North Dakota, United States, 58103
- Research Site
-
-
Ohio
-
Canal Fulton, Ohio, United States, 44614
- Research Site
-
Cincinnati, Ohio, United States, 45219
- Research Site
-
Cleveland, Ohio, United States, 44126
- Research Site
-
Delaware, Ohio, United States, 43015
- Research Site
-
Elyria, Ohio, United States, 44035
- Research Site
-
Parma Hts., Ohio, United States, 44130
- Research Site
-
Sandusky, Ohio, United States, 44870
- Research Site
-
Springfield, Ohio, United States, 45504
- Research Site
-
Toledo, Ohio, United States, 43606
- Research Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Research Site
-
Oklahoma City, Oklahoma, United States, 73120
- Research Site
-
Oklahoma City, Oklahoma, United States, 73135
- Research Site
-
Tulsa, Oklahoma, United States, 74104
- Research Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, United States, 16602
- Research Site
-
Bethlehem, Pennsylvania, United States, 18015
- Research Site
-
Camp Hill, Pennsylvania, United States, 17011
- Research Site
-
Doylestown, Pennsylvania, United States, 18901
- Research Site
-
Erie, Pennsylvania, United States, 16508
- Research Site
-
Indiana, Pennsylvania, United States, 15701
- Research Site
-
Johnstown, Pennsylvania, United States, 15905
- Research Site
-
Kittanning, Pennsylvania, United States, 16201
- Research Site
-
Langhorne, Pennsylvania, United States, 19047
- Research Site
-
Philadelphia, Pennsylvania, United States, 19152
- Research Site
-
Philadelphia, Pennsylvania, United States, 19153
- Research Site
-
Pittsburgh, Pennsylvania, United States, 15240
- Research Site
-
Sellersville, Pennsylvania, United States, 18960
- Research Site
-
Tyrone, Pennsylvania, United States, 16686
- Research Site
-
York, Pennsylvania, United States, 17405
- Research Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Research Site
-
Greer, South Carolina, United States, 29651
- Research Site
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57108
- Research Site
-
-
Tennessee
-
Bristol, Tennessee, United States, 37620
- Research Site
-
Kingsport, Tennessee, United States, 37660
- Research Site
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Knoxville, Tennessee, United States, 37912
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Memphis, Tennessee, United States, 38163
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Texas
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Arlington, Texas, United States, 76014
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Carrollton, Texas, United States, 75101
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Dallas, Texas, United States, 75220
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Dallas, Texas, United States, 75243
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Fort Worth, Texas, United States, 76107
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Georgetown, Texas, United States, 78626
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77025
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Houston, Texas, United States, 77095
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Irving, Texas, United States, 75039
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Katy, Texas, United States, 77450
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Kingwood, Texas, United States, 77339
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McAllen, Texas, United States, 78503
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Midland, Texas, United States, 79707
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Odessa, Texas, United States, 79761
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Plano, Texas, United States, 75023
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San Antonio, Texas, United States, 78249
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Tomball, Texas, United States, 77375
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Tyler, Texas, United States, 75701
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Utah
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Ogden, Utah, United States, 84405
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Salt Lake City, Utah, United States, 84124
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Salt Lake City, Utah, United States, 84102
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Vermont
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Bennington, Vermont, United States, 05201
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Virginia
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Burke, Virginia, United States, 22015
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Danville, Virginia, United States, 24541
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Manassas, Virginia, United States, 20110
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Manassas, Virginia, United States, 20109
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Norfolk, Virginia, United States, 23502
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Richmond, Virginia, United States, 23249
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Richmond, Virginia, United States, 23836
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Washington
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Burien, Washington, United States, 98166
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Puyallup, Washington, United States, 98372
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Seattle, Washington, United States, 98104
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Spokane, Washington, United States, 99204
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Spokane, Washington, United States, 99218
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Tacoma, Washington, United States, 98405
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Wisconsin
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Madison, Wisconsin, United States, 52713
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Madison, Wisconsin, United States, 53719
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Milwaukee, Wisconsin, United States, 53295
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Wausau, Wisconsin, United States, 54401
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Hanoi, Vietnam, 100000
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Ho Chi Minh City, Vietnam, 700000
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Ho Chi Minh City, Vietnam, 70000
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Ho Chi Minh City, Vietnam, 9000
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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 to 130 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged ≥40 years
- Diagnosed with Type 2 Diabetes
- High Risk for Cardiovascular events
Exclusion Criteria:
- Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Chronic cystitis and/or recurrent urinary tract infections
- Pregnant or breast-feeding patients
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
|
Oral dose (od)
|
PLACEBO_COMPARATOR: Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
|
Oral dose (od)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Time Frame: up to 5.2 years
|
Safety and co-primary efficacy
|
up to 5.2 years
|
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Time Frame: up to 5.2 years
|
Co-primary efficacy
|
up to 5.2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.
Time Frame: up to 5.2 years
|
Secondary
|
up to 5.2 years
|
Subjects Included in the Endpoint of All-cause Mortality.
Time Frame: up to 5.2 years
|
Secondary
|
up to 5.2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anna Maria Langkilde, MD, AstraZeneca Sweden
- Study Chair: Marc S Sabatine, MD, MPH, TIMI Study Group, Boston, MA, USA
- Principal Investigator: Stephen D Wiviott, MD, TIMI Study Group, MA, USA
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
- Mosenzon O, Raz I, Wiviott SD, Schechter M, Goodrich EL, Yanuv I, Rozenberg A, Murphy SA, Zelniker TA, Langkilde AM, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Wilding JPH, McGuire DK, Bhatt DL, Leiter LA, Cahn A, Dwyer JP, Heerspink HJL, Sabatine MS. Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial. Diabetes Care. 2022 Oct 1;45(10):2350-2359. doi: 10.2337/dc22-0382.
- Oyama K, Raz I, Cahn A, Goodrich EL, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin According to Background Use of Cardiovascular Medications in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2022 Sep 1;7(9):914-923. doi: 10.1001/jamacardio.2022.2006.
- Furtado RHM, Raz I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Aylward P, Dalby AJ, Dellborg M, Dimulescu D, Nicolau JC, Oude Ophuis AJM, Cahn A, Mosenzon O, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial. Circulation. 2022 May 24;145(21):1581-1591. doi: 10.1161/CIRCULATIONAHA.121.058103. Epub 2022 May 5.
- Cahn A, Wiviott SD, Mosenzon O, Goodrich EL, Murphy SA, Yanuv I, Rozenberg A, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Raz I. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58. Diabetes Care. 2022 Apr 1;45(4):938-946. doi: 10.2337/dc21-1744.
- Oyama K, Raz I, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Park KS, Goudev A, Diaz R, Spinar J, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE-TIMI 58 trial. Eur Heart J. 2022 Aug 14;43(31):2958-2967. doi: 10.1093/eurheartj/ehab530.
- Mosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.
- Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.
- Zelniker TA, Raz I, Mosenzon O, Dwyer JP, Heerspink HHJL, Cahn A, Goodrich EL, Im K, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):801-810. doi: 10.1001/jamacardio.2021.0660.
- Cahn A, Raz I, Leiter LA, Mosenzon O, Murphy SA, Goodrich EL, Yanuv I, Rozenberg A, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Wiviott SD. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58. Diabetes Care. 2021 May;44(5):1159-1167. doi: 10.2337/dc20-2492. Epub 2021 Mar 2.
- O'Donoghue ML, Kato ET, Mosenzon O, Murphy SA, Cahn A, Herrera M, Tankova T, Smahelova A, Merlini P, Gause-Nilsson I, Langkilde AM, McGuire DK, Wilding JPH, Leiter LA, Bhatt DL, Raz I, Sabatine MS, Wiviott SD. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Jun;64(6):1226-1234. doi: 10.1007/s00125-021-05399-2. Epub 2021 Feb 20.
- Bonaca MP, Wiviott SD, Zelniker TA, Mosenzon O, Bhatt DL, Leiter LA, McGuire DK, Goodrich EL, De Mendonca Furtado RH, Wilding JPH, Cahn A, Gause-Nilsson IAM, Johanson P, Fredriksson M, Johansson PA, Langkilde AM, Raz I, Sabatine MS. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747. doi: 10.1161/CIRCULATIONAHA.119.044775. Epub 2020 Aug 3.
- Zelniker TA, Bonaca MP, Furtado RHM, Mosenzon O, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Budaj A, Kiss RG, Padilla F, Gause-Nilsson I, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234. doi: 10.1161/CIRCULATIONAHA.119.044183. Epub 2020 Jan 27.
- Cahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.
- 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.
- Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10. Erratum In: Lancet Diabetes Endocrinol. 2019 Aug;7(8):e20.
- Furtado RHM, Bonaca MP, Raz I, Zelniker TA, Mosenzon O, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Nicolau JC, Gause-Nilsson IAM, Fredriksson M, Langkilde AM, Sabatine MS, Wiviott SD. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation. 2019 May 28;139(22):2516-2527. doi: 10.1161/CIRCULATIONAHA.119.039996. Epub 2019 Mar 18.
- Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.
- Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
- Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Bansilal S, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Gause-Nilsson IA, Langkilde AM, Johansson PA, Sabatine MS. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89. doi: 10.1016/j.ahj.2018.01.012. Epub 2018 Feb 7.
- Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.
- Bloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7. doi: 10.1016/j.jash.2016.01.001. No abstract available.
- Leiter LA, Cefalu WT, de Bruin TW, Xu J, Parikh S, Johnsson E, Gause-Nilsson I. Long-term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease. Diabetes Obes Metab. 2016 Aug;18(8):766-74. doi: 10.1111/dom.12666. Epub 2016 May 12.
Helpful Links
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 (ACTUAL)
April 25, 2013
Primary Completion (ACTUAL)
September 11, 2018
Study Completion (ACTUAL)
September 11, 2018
Study Registration Dates
First Submitted
November 15, 2012
First Submitted That Met QC Criteria
November 20, 2012
First Posted (ESTIMATE)
November 21, 2012
Study Record Updates
Last Update Posted (ACTUAL)
December 26, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1693C00001
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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