- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403767
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
April 10, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
Study Overview
Status
Completed
Conditions
Detailed Description
Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots).
Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study).
Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5.
Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD.
Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD.
The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.
Study Type
Interventional
Enrollment (Actual)
14269
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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Bahia Blanca, Argentina
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Buenos Aires, Argentina
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Cipolletti, Argentina
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Ciudad Autonoma 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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Mar Del Plata, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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Salta, Argentina
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San Martin, Argentina
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Santa Fe, Argentina
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Tucuman, Argentina
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Adelaide, Australia
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Auchenflower, Australia
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Bedford Park, Australia
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Box Hill, Australia
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Caboolture, Australia
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Cairns, Australia
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Camperdown, Australia
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Chermside, Australia
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Clayton, Australia
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Coffs Harbour, Australia
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Footscray, Australia
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Garran, Australia
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Geelong, Australia
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Gosford, Australia
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Heidelberg Heights, Australia
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Herston, Australia
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Hobart, Australia
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Joondalup, Australia
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Lismore, Australia
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Liverpool, Australia
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Miranda, Australia
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Nedlands, Australia
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New Lambton Heights, Australia
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Parkville, Australia
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Penrith, Australia
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Prahran, Australia
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Reservoir, Australia
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Southport, Australia
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Windsor, Australia
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Wolloongabba, Australia
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Feldkirch Vorarlberg Vorarlber, Austria
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Graz, Austria
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Tulln Niederosterreich Niedero, Austria
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Wien, Austria
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Wien N/A, Austria
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Wien Wien, Austria
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Antwerpen, Belgium
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Bonheiden, Belgium
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Brasschaat, Belgium
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Brugge, Belgium
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Brussel, Belgium
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Bruxelles, Belgium
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Gent, Belgium
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Haine-Saint-Paul, Belgium
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Leuven, Belgium
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Mol, Belgium
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Nivelles, Belgium
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Ottignies, Belgium
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Roeselare, Belgium
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Seraing, Belgium
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Tienen, Belgium
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Brasilia, Brazil
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Campina Grande Do Sul, Brazil
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Campinas, Brazil
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Campo Grande, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Goiania, Brazil
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Goiânia, Brazil
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Maceio, Brazil
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Marilia, Brazil
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Maringa, 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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Rio De Janeiro Br, Brazil
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Salvador, Brazil
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Santo Andre, Brazil
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Sao Caetano Do Sul, Brazil
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Sao Paulo, Brazil
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Sorocaba, Brazil
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São José Do Rio Preto, Brazil
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São Paulo, Brazil
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Uberlandia, Brazil
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Dimitrovgrad, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Russel, Bulgaria
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Sofia, Bulgaria
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Veliko Turnovo, Bulgaria
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Abbotsford, British Columbia, Canada
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Burnaby, British Columbia, Canada
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Campbell River, British Columbia, Canada
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Delta, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Langley, British Columbia, Canada
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New Westminster, British Columbia, Canada
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Penticton, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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West Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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New Brunswick
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, 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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Sydney, Nova Scotia, Canada
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Ontario
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Ajax, Ontario, Canada
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Beamsville, Ontario, Canada
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Belleville, Ontario, Canada
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Cambridge, Ontario, Canada
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Corunna, Ontario, Canada
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Courtice, Ontario, Canada
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E. London, Ontario, Canada
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Etobicoke, Ontario, Canada
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Fort Erie, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Listowel, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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North Bay, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Parry Sound, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Sarnia, Ontario, Canada
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Sault Ste Marie, Ontario, Canada
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Scarborough, Ontario, Canada
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Strathroy, Ontario, Canada
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Sudbury, Ontario, Canada
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Thornhill, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Whitby, Ontario, Canada
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York, Ontario, Canada
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Quebec
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Joliette, Quebec, Canada
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Jonquiere, Quebec, Canada
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Lachine, Quebec, Canada
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Longueuil, Quebec, Canada
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Saint-Jerome, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St-Leonard, Quebec, Canada
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Saskatchewan
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North Battleford, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Arica I Region, Chile
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Chila, Chile
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Concepción Viii, Chile
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Osorno X Region, Chile
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Osorno X Región, Chile
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Rancagua Vi Region, Chile
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San Felipe V Region, Chile
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Santiago De Chile Rm, Chile
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Santiago Rm, Chile
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Temuco Ix, Chile
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Valdivia X Región, Chile
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Viña Del Mar V Región, Chile
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Bei Jing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Changzhou, China
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Chengdu, China
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Chongqing, China
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Dalian, China
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Daqing, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Harbin, China
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Jinan, China
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Nanjing, China
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Shanghai, China
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Shenyang, China
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Su Zhou, China
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Suzhou, China
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Tianjin, China
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Wuhan, China
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Xian, China
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Barranquilla, Colombia
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Barranquilla Atlántico Atlanti, Colombia
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Bogota D C, Colombia
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Bogota Dc, Colombia
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Bogotá Dc, Colombia
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Bogotá Dc Dc, Colombia
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Cali Valle Del Cauca, Colombia
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Cali Valley Del Cauca, Colombia
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Medellin, Colombia
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Medellin Antioquia, Colombia
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Santander, Colombia
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Brno 2, Czech Republic
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Chomutov, Czech Republic
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Hradec Kralove, Czech Republic
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Karviná 4, Czech Republic
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Kutna Hora N/A, Czech Republic
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Liberec, Czech Republic
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Litomysl, Czech Republic
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Náchod 1, Czech Republic
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Olomouc, Czech Republic
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Ostrava, Czech Republic
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Pardubice, Czech Republic
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Praha, Czech Republic
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Praha 1, Czech Republic
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Praha 10 N/A, Czech Republic
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Praha 2, Czech Republic
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Praha 4, Czech Republic
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Praha 5, Czech Republic
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Praha 8, Czech Republic
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Slany, Czech Republic
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Svitavy, Czech Republic
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Svitavy 2, Czech Republic
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Trutnov, Czech Republic
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Uherské Hradistì 6, Czech Republic
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Zlín 1, Czech Republic
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Esbjerg, Denmark
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Frederiksberg, Denmark
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Gentofte, Denmark
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Hellerup, Denmark
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Helsingør, Denmark
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Hvidovre, Denmark
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Koege, Denmark
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København, Denmark
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Næstved, Denmark
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Roskilde, Denmark
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Slagelse, Denmark
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Viborg, Denmark
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Helsinki, Finland
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Jyväskylä N/A, Finland
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Kuopio, Finland
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Mikkeli, Finland
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Oulu, Finland
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Turku, Finland
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Albi, France
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Arras, France
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Bayonne, France
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Belfort, France
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Besancon N/A, France
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Bourg En Bresse, France
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Brest, France
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Béziers Languedoc-Roussillon, France
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Carcassonne, France
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Clermont Ferrand, France
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Corbeil Essonnes, France
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Lille, France
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Marseille, France
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Montbeliard, France
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Montpellier, France
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Paris, France
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Paris Cedex 14, France
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Perpignan, France
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Poitiers, France
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Saint-Brieuc, France
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St Jean De Verges, France
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Strasbourg, France
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Thionville, France
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Toulouse, France
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Trelivan, France
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Aalen, Germany
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Berlin, Germany
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Berlin/Spandau, Germany
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Biberach, Germany
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Bochum, Germany
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Bonn, Germany
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Chemnitz, Germany
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Coburg, Germany
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Dachau, Germany
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Dortmund, Germany
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Dresden, Germany
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Duisburg, Germany
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Ebersbach, Germany
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Eilenburg, Germany
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Erfurt, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg, Germany
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Greifswald, Germany
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Halle, Germany
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Hamburg, Germany
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Hartmannsdorf, Germany
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Heidelberg, Germany
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Henstedt-Rhen, Germany
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Herford, Germany
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Homburg/Saar, Germany
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Jena, Germany
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Julich, Germany
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Kamen, Germany
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Karlsbad, Germany
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Kassel, Germany
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Kirchzarten, Germany
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Krefeld, Germany
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Leipzig, Germany
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Ludwigsburg, Germany
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Ludwigshafen, Germany
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Lüneburg, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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Markkleeberg, Germany
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Meißen, Germany
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Melsungen, Germany
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Monchengladbach, Germany
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Munchen, Germany
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Mühldorf, Germany
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Mülheim, Germany
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Münster, Germany
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Neuwied, Germany
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Nienburg, Germany
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Nuernberg, Germany
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Paderborn, Germany
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Potsdam, Germany
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Riesa, Germany
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Rottweil, Germany
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Sachsen, Germany
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Siegen, Germany
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Ulm, Germany
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Wermsdorf, Germany
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Witten, Germany
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Wolmirstedt, Germany
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Wuppertal, Germany
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Athens Attica, Greece
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Ioannina, Greece
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Maroussi Athens, Greece
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Patra, Greece
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Piraeus Attica, Greece
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Tripoli, Greece
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Voula Attica, Greece
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Aberdeen, Hong Kong
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Hk, Hong Kong
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Kln, Hong Kong
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Sha Tin, Hong Kong
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Budapest, Hungary
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Budapest N/A, Hungary
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Budapest Nap, Hungary
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Debrecen County, Hungary
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Eger, Hungary
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Gyongyos, Hungary
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Gyõr, Hungary
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Kesckemet, Hungary
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Miskolc, Hungary
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Nyiregyhaza, Hungary
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Pecs, Hungary
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Szeged, Hungary
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Szekszard, Hungary
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Szombathely, Hungary
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Veszprem, Hungary
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Zalaegerszeg, Hungary
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Ahmedabad, India
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Bangalore, India
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Bikaner, India
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Chennai, India
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Coimbatore, India
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Gandhinagar Guiarat, India
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Hyderabad, India
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Hyderabad Andra Pradesh, India
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Jalandhar, India
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Madurai, India
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Mangalore, India
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Mumbai, India
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Mysore, India
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New Delhi, India
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Pune, India
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Suraj, India
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Vadodara, India
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Vishakapatnam, India
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Afula, Israel
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Ashkelon, Israel
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Hadera, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Nazareth, Israel
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Netanya, Israel
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Petach-Tikva, Israel
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Petah-Tikva, Israel
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Poriya, Israel
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Rehovot, Israel
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Safed, Israel
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Tel Aviv, Israel
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Tel Hashomer, Israel
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Zerifin, Israel
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Anyang, Korea, Republic of
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Daegu, Korea, Republic of
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Daejeon, Korea, Republic of
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Goyang, Korea, Republic of
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Kyonggi-Do, Korea, Republic of
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Pusan, Korea, Republic of
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Seoul, Korea, Republic of
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Sungnam, Korea, Republic of
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Suwon, Korea, Republic of
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Panevezys, Lithuania
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Siauliai, Lithuania
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Vilnius, Lithuania
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Kelantan, Malaysia
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Kuala Lumpur, Malaysia
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Sarawak, Malaysia
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Aguascalientes, Mexico
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Ciudad De Mexico, Mexico
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Culiacán Sinaloa/Mèxico, Mexico
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Guadalajara, Mexico
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Hermosillo, Mexico
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Monterrey, Mexico
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Monterrey Nuevo Leòn, Mexico
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Queretaro, Mexico
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San Luis Potosi, Mexico
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Sinaloa, Mexico
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Zapopan, Mexico
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'S-Gravenhage, Netherlands
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Alkmaar, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Delft, Netherlands
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Den Bosch, Netherlands
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Den Haag, Netherlands
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Gc Tilburg, Netherlands
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Gouda, Netherlands
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Groningen, Netherlands
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Haarlem, Netherlands
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Heerlen, Netherlands
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Hoofddorp, Netherlands
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Hoorn Nh, Netherlands
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Leeuwarden, Netherlands
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Leidschendam, Netherlands
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Maastricht, Netherlands
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Meppel, Netherlands
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Nijmegen, Netherlands
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Schiedam, Netherlands
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Veldhoven, Netherlands
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Christchurch, New Zealand
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Dunedin, New Zealand
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Grafton, New Zealand
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Hamilton, New Zealand
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Takapuna Auckland, New Zealand
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Wellington, New Zealand
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Alesund, Norway
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Bergen, Norway
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Elverum, Norway
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Hamar, Norway
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Jessheim, Norway
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Lillehammer, Norway
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Moss, Norway
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Oslo, Norway
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Sandefjord, Norway
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Sandnes, Norway
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Sandvika, Norway
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Skedsmokorset, Norway
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L41 Lima Lima, Peru
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Lima, Peru
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Lima 1 Lima Lima, Peru
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Cebuu City, Philippines
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Davao City, Philippines
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Iloilo City, Philippines
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Manila City, Philippines
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Quezon City, Philippines
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Bydgoszcz, Poland
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Bydgoszcz N/A, Poland
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Gdansk, Poland
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Gdynia, Poland
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Katowice, Poland
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Katowice-Ochojec, Poland
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Krakow, Poland
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Lodz, Poland
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Olawa, Poland
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Olsztyn, Poland
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Opole, Poland
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Ostrowiec N/A, Poland
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Piotrkow Trybunalski, Poland
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Plock, Poland
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Poznan, Poland
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Siedlce, Poland
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Sieradz N/A, Poland
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Skierniewice, Poland
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Starogard Gdanski Nap, Poland
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Szczecin, Poland
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Szczecin Nap, Poland
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Torun, Poland
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Warsaw, Poland
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Warszawa, Poland
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Warszawa N/A, Poland
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Wloclawek, Poland
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Wroclaw, Poland
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Wroclaw N/A, Poland
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Zyrardow N/A, Poland
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Brasov, Romania
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Bucharest, Romania
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Bucuresti, Romania
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Craiova, Romania
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Focsani, Romania
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Iasi, Romania
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Oradea, Romania
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Sibiu, Romania
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Suceava, Romania
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Tg Mures, Romania
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Timisoara, Romania
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Barnaul, Russian Federation
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Chelyabinsk, Russian Federation
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Chelyabinsk Chelyabinsk Region, Russian Federation
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Ekaterinburg, Russian Federation
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Kemerovo, Russian Federation
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Krasnoyarsk, Russian Federation
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Moscow, Russian Federation
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Moscow N/A, Russian Federation
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Nizhni Novgorod, Russian Federation
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Novosibirsk, Russian Federation
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Novosibirsk Nap, Russian Federation
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Orenburg, Russian Federation
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Perm, Russian Federation
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Ryazan, 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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Smolensk, Russian Federation
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St Petersburg, Russian Federation
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St. Petersburg, Russian Federation
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Tomsk, Russian Federation
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Tyumen Tyumen Region, Russian Federation
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Yaroslavl, Russian Federation
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Yaroslavl Nap, Russian Federation
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Singapore, Singapore
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Bloemfontein Free State, South Africa
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Bloemfontein Orange Free State, South Africa
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Cape Town, South Africa
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Cape Town Western Cape, South Africa
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Centurion Gauteng, South Africa
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Durban Kwa Zulu Natal, South Africa
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Johannesburg Gauteng, South Africa
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Kempton Park Gauteng, South Africa
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Port Elizabeth Eastern Cape, South Africa
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Pretoria Gauteng, South Africa
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Somerset West Western Cape, South Africa
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Van Der Bijl Park, South Africa
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Worcester Western Cape, South Africa
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A Coruna, Spain
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Alicante N/A, Spain
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Almeria, Spain
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Baracaldo Vizcaya, Spain
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Barcelona, Spain
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Burgos, Spain
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Guadalajara, Spain
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La Corona, Spain
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Madrid, Spain
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Malaga, Spain
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Oviedo, Spain
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Palma De Mallorca, Spain
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Pamplona, Spain
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Pontevedra, Spain
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Sabadell, Spain
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San Sebastián Guipúzcoa, Spain
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Sevilla, Spain
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Terrassa, Spain
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Valencia, Spain
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Valladolid, Spain
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Ljungby, Sweden
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Lund, Sweden
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Sala, Sweden
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Skövde, Sweden
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Uppsala, Sweden
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Basel Bs, Switzerland
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Bruderholz, Switzerland
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Geneve, Switzerland
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Zurich, Switzerland
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Changhua, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Tamshui, Taiwan
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Tao-Yuan, Taiwan
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Bangkok, Thailand
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Bangkok Noi, Thailand
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Chiang Mai, Thailand
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Pathumthani, Thailand
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Phathumwan, Thailand
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Ratchatewi, Thailand
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Adana, Turkey
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Ankara, Turkey
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Antalya, Turkey
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Aydin, Turkey
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Denizli, Turkey
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Diyarbakir, Turkey
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Eskisehir, Turkey
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Görükle, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Izmit, Turkey
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Kayseri, Turkey
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Konya, Turkey
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Malatya Nap, Turkey
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Mersin, Turkey
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Samsun, Turkey
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Cherkassy, Ukraine
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Chernigiv, Ukraine
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Dnepropetrovsk, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kharkov, Ukraine
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Kirovograd, Ukraine
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Kyiv, Ukraine
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Lugansk, Ukraine
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Lviv, Ukraine
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O1103 Kyiv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Simferopil, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhgorod, Ukraine
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Vinnitsya, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomyr, Ukraine
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-
-
-
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Aberdeen, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Bournemouth, United Kingdom
-
Cambridgeshire, United Kingdom
-
Chelmsford, United Kingdom
-
Chesterfield, United Kingdom
-
Colchester, United Kingdom
-
Craigavon, United Kingdom
-
Devon, United Kingdom
-
Dundee, United Kingdom
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Glasgow, United Kingdom
-
Harrogate, United Kingdom
-
Hull, United Kingdom
-
Leicester, United Kingdom
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Lincoln, United Kingdom
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Liverpool, United Kingdom
-
London, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Romford, United Kingdom
-
Sheffield, United Kingdom
-
Stirling, United Kingdom
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Stoke On Trent, United Kingdom
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York, United Kingdom
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-
-
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Alabama
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Geneva, Alabama, United States
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Mobile, Alabama, United States
-
Pell City, Alabama, United States
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Arizona
-
Glendale, Arizona, United States
-
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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California
-
Anaheim, California, United States
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Bakersfield, California, United States
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Carmichael, California, United States
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Corona, California, United States
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Fair Oaks, California, United States
-
Glendale, California, United States
-
Healdsburg, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
-
Los Angeles, California, United States
-
Los Gatos, California, United States
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Mission Viejo, California, United States
-
Modesto, California, United States
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Mountain View, California, United States
-
Northridge, California, United States
-
Oakland, California, United States
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Orange, California, United States
-
Pismo Beach, 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 Leandro, California, United States
-
Santa Clara, California, United States
-
Santa Monica, California, United States
-
Santa Rosa, California, United States
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Sylmar, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Yuba City, California, United States
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Colorado
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Pueblo, Colorado, United States
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Connecticut
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Danbury, Connecticut, United States
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Guilford, Connecticut, United States
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Delaware
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Newark, Delaware, United States
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Florida
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Debary, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Fort Walton Beach, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Hudson, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Largo, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Palm Beach Gardens, Florida, United States
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Palm Harbor, Florida, United States
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Port Charlotte, Florida, United States
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Safety Harbor, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Georgia
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Savannah, Georgia, United States
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Idaho
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Nampa, Idaho, United States
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Illinois
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Aurora, Illinois, United States
-
Bannockburn, Illinois, United States
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Chicago, Illinois, United States
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Evergreen Park, Illinois, United States
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Fulton, Illinois, United States
-
Lombard, Illinois, United States
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Melrose Park, Illinois, United States
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Moline, Illinois, United States
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Park Ridge, Illinois, United States
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Peoria, Illinois, United States
-
Quincy, Illinois, United States
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Rock Island, Illinois, United States
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Rockford, Illinois, United States
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Springfield, Illinois, United States
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Watseka, Illinois, United States
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Indiana
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Anderson, Indiana, United States
-
Hammond, Indiana, United States
-
Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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Muncie, Indiana, United States
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Munster, Indiana, United States
-
South Bend, Indiana, United States
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Iowa
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Waterloo, Iowa, United States
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Kentucky
-
Crestview Hills, Kentucky, United States
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Edgewood, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Madisonville, Kentucky, United States
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Mt Sterling, Kentucky, United States
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Owensboro, Kentucky, United States
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Louisiana
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Houma, Louisiana, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Thibodaux, Louisiana, United States
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Vidalia, Louisiana, United States
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Maine
-
Bangor, Maine, United States
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Scarborough, Maine, United States
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Maryland
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Annapolis, Maryland, United States
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Beltsville, Maryland, United States
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Columbia, Maryland, United States
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Salisbury, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Brighton, Massachusetts, United States
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Framingham, Massachusetts, United States
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Michigan
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Bay City, Michigan, United States
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Bridgman, Michigan, United States
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Chelsea, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Mount Clemens, Michigan, United States
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Petoskey, Michigan, United States
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Traverse City, Michigan, United States
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Troy, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Mississippi
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Picayune, Mississippi, United States
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Tupelo, Mississippi, United States
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Missouri
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Lexington, Missouri, United States
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Saint Louis, Missouri, United States
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Springfield, Missouri, United States
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Montana
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Anaconda, Montana, United States
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Great Falls, Montana, United States
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-
Nebraska
-
Beatrice, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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-
New Hampshire
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Manchester, New Hampshire, United States
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New Jersey
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Bridgewater, New Jersey, United States
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Elmer, New Jersey, United States
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Haddon Heights, New Jersey, United States
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New Brunswick, New Jersey, United States
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Paterson, New Jersey, United States
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Ridgewood, New Jersey, United States
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Sewell, New Jersey, United States
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Springfield, New Jersey, United States
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Toms River, New Jersey, United States
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Wayne, New Jersey, United States
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-
New Mexico
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Albuquerque, New Mexico, United States
-
-
New York
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Bronx, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
-
Cortlandt Manor, New York, United States
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East Syracuse, New York, United States
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New York, New York, United States
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Northport, New York, United States
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Saratoga Springs, New York, United States
-
Schenectady, New York, United States
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Staten Island, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Williamsville, New York, United States
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North Carolina
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Asheville, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Jacksonville, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Reidsville, North Carolina, United States
-
Rocky Mount, North Carolina, United States
-
Statesville, North Carolina, United States
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Winston Salem, North Carolina, United States
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-
North Dakota
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Fargo, North Dakota, United States
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Minot, North Dakota, United States
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Ohio
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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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Fairfield, Ohio, United States
-
Mansfield, Ohio, United States
-
Massillon, Ohio, United States
-
Maumee, Ohio, United States
-
Toledo, Ohio, United States
-
Zanesville, Ohio, United States
-
-
Oklahoma
-
Bartlesville, Oklahoma, United States
-
Midwest City, Oklahoma, United States
-
Norman, Oklahoma, United States
-
Oklahoma City, Oklahoma, United States
-
Yukon, Oklahoma, United States
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Oregon
-
Portland, Oregon, United States
-
-
Pennsylvania
-
Beaver, Pennsylvania, United States
-
Bethlehem, Pennsylvania, United States
-
Danville, Pennsylvania, United States
-
Doylestown, Pennsylvania, United States
-
Jeannette, Pennsylvania, United States
-
Jersey Shore, Pennsylvania, United States
-
Lansdale, Pennsylvania, United States
-
Leetsdale, Pennsylvania, United States
-
Lewistown, Pennsylvania, United States
-
Norristown, Pennsylvania, United States
-
North Wales, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
-
Philipsburg, Pennsylvania, United States
-
Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
-
Sayre, Pennsylvania, United States
-
Scranton, Pennsylvania, United States
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Shippensburg, Pennsylvania, United States
-
State College, Pennsylvania, United States
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Topton, Pennsylvania, United States
-
Wilkes Barre, Pennsylvania, United States
-
Wormleysburg, Pennsylvania, United States
-
Wyomissing, Pennsylvania, United States
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Rhode Island
-
Pawtucket, Rhode Island, United States
-
Westerly, Rhode Island, United States
-
-
South Carolina
-
Anderson, South Carolina, United States
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Charleston, South Carolina, United States
-
Columbia, South Carolina, United States
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Easley, South Carolina, United States
-
Sumter, South Carolina, United States
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South Dakota
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Rapid City, South Dakota, United States
-
-
Tennessee
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Athens, Tennessee, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Harriman, Tennessee, United States
-
Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
-
Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
-
Lexington, Tennessee, United States
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Memphis, Tennessee, United States
-
Nashville, Tennessee, United States
-
-
Texas
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Amarillo, Texas, United States
-
Beaumont, Texas, United States
-
Brownsville, Texas, United States
-
Corpus Christi, Texas, United States
-
Daingerfield, Texas, United States
-
Dallas, Texas, United States
-
Desoto, Texas, United States
-
Fort Sam Houston, Texas, United States
-
Fort Worth, Texas, United States
-
Houston, Texas, United States
-
Humble, Texas, United States
-
Hurst, Texas, United States
-
Kerrville, Texas, United States
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Kingwood, Texas, United States
-
Lubbock, Texas, United States
-
Mcallen, Texas, United States
-
Odessa, Texas, United States
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Plano, Texas, United States
-
San Antonio, Texas, United States
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Sugar Land, Texas, United States
-
Tomball, Texas, United States
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Victoria, Texas, United States
-
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Utah
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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Vermont
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Burlington, Vermont, United States
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Virginia
-
Blacksburg, Virginia, United States
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Chester, Virginia, United States
-
Danville, Virginia, United States
-
Fairfax, Virginia, United States
-
Fredericksburg, Virginia, United States
-
Lynchburg, Virginia, United States
-
Richmond, Virginia, United States
-
Roanoke, Virginia, United States
-
Virginia Beach, Virginia, United States
-
Williamsburg, Virginia, United States
-
-
Washington
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Bellingham, Washington, United States
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Port Orchard, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
-
Vancouver, Washington, United States
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Wisconsin
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Burlington, Wisconsin, United States
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Elkhorn, Wisconsin, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Wausau, Wisconsin, United States
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-
-
-
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Caracas, Venezuela
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Maracaibo Estado Zulia, Venezuela
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Maracay Estado Aragua, Venezuela
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
- History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus
Exclusion Criteria:
- Significant mitral stenosis
- Transient atrial fibrillation caused by a reversible disorder
- Active internal bleeding
- Severe disabling stroke
- History of intracranial bleeding
- Hemorrhagic disorders
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Warfarin
|
Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use.
Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years
Form-tablet, Route=oral administration.
Number of rivaroxaban placebo determined by the number of warfarin tablets taken.
Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
Experimental: Rivaroxaban
|
Type=exact number, unit=mg, number=20, form=tablet, route=oral use.
One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)
Form=tablet, route=oral.
One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days).
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days).
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment.
The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.
|
Up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment.
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment.
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a stroke while on treatment.
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment.
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
Time Frame: Up to 4 years
|
The number of patients with the first occurrence of a myocardial infarction while on treatment.
The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
|
Up to 4 years
|
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
Time Frame: Up to 4 years
|
The number of patients with the occurrence of vascular death while on treatment.
The statistical analysis is based on time from randomization to the event while on treatment.
|
Up to 4 years
|
All-cause Mortality
Time Frame: Up to 4 years
|
The number of patients who died due to any cause while on treatment.
The statistical analysis is based on time from randomization to the event while on treatment.
|
Up to 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.
- Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.
- Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.
- Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.
- Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.
- Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.
- Sun Y, Hu D, Stevens S, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Fox KAA, Patel MR. Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial. Thromb Res. 2017 Aug;156:184-190. doi: 10.1016/j.thromres.2017.04.010. Epub 2017 Apr 13.
- Lindner SM, Fordyce CB, Hellkamp AS, Lokhnygina Y, Piccini JP, Breithardt G, Mahaffey KW, Singer DE, Hacke W, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Becker RC, Fox KA, Patel MR; ROCKET AF Steering Committee and Investigators. Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis. Circulation. 2017 Mar 7;135(10):1001-1003. doi: 10.1161/CIRCULATIONAHA.116.024666. No abstract available.
- Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR; ROCKET AF Steering Committee and Investigators. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 5;134(1):37-47. doi: 10.1161/CIRCULATIONAHA.116.021890. Erratum In: Circulation. 2016 Aug 23;134(8):e114. Circulation. 2020 Feb 25;141(8):e98.
- Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL, Breithardt G, Singer DE, Hankey GJ, Hacke W, Becker RC, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Steering Committee & Investigators; ROCKET AF Steering Committee Investigators. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016 Mar 8;5(3):e002197. doi: 10.1161/JAHA.115.002197.
- Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Lokhnygina Y, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Califf RM, Fox KA, Patel MR; ROCKET AF Steering Committee & Investigators. Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban. Heart. 2016 Jul 1;102(13):1036-43. doi: 10.1136/heartjnl-2015-308120. Epub 2016 Feb 17.
- Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.
- Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.
- Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.
- Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.
- Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.
- Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.
- Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.
- Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.
- van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.
- Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.
- Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.
- Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.
- Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.
- Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
- ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.
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
December 1, 2006
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
November 23, 2006
First Submitted That Met QC Criteria
November 23, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Estimate)
April 29, 2014
Last Update Submitted That Met QC Criteria
April 10, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Embolism and Thrombosis
- Arrhythmias, Cardiac
- Stroke
- Embolism
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Warfarin
Other Study ID Numbers
- CR012157
- 39039039AFL3001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
- ROCKET AF (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
- 2006-004595-13 (EudraCT Number)
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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