Trial Condition(s):

Stroke

Rivaroxaban versus Aspirin in secondary prevention of stroke and prevention of systemic embolism in patients with recent embolic stroke of undetermined source (ESUS) (NAVIGATE ESUS)

Bayer Identifier:

16573

ClinicalTrials.gov Identifier:

NCT02313909

EudraCT Number:

2013-000768-27

EU CT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Inclusion Criteria
-  Recent ESUS (between 7 days and 6 months), defined as:
  -  Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
  -  Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and
  -  No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
  -  No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
  -  No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
Exclusion Criteria
-  Severely disabling stroke (modified Rankin score ≥4)
 -  Indication for chronic anticoagulation or antiplatelet therapy
 -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

Trial Summary

Enrollment Goal
7213
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Roma, Italy, 00161

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São Paulo, Brazil, 01228-000

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Basel, Switzerland, 4056

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Hamilton, Canada, L8L 2X2

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Brussel, Belgium, 1090

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Lund, Sweden, 221 85

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Buenos Aires, Argentina, 1428

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Moscow, Russia, 117997

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Helsinki, Finland, 00029

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México D.F., Mexico

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Santiago, Chile, 7650567

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Seoul, South Korea, 110-744

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Philadelphia, United States, 19104

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San Antonio, United States, 78229

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Tucson, United States, 85724

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Glasgow, United Kingdom, G51 4TF

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London, United Kingdom, W6 8RP

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Badalona, Spain, 08916

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Nedlands, Australia, 6009

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Berlin, Germany, 12200

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Milano, Italy, 20132

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Perugia, Italy, 06012

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Perugia, Italy, 06156

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Mar del Plata, Argentina, B7602CBM

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Buenos Aires, Argentina, C1437JCP

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Wermsdorf, Germany, 04779

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Regensburg, Germany, 93053

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Hamburg, Germany, 22417

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Hannover, Germany, 30625

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Warszawa, Poland, 02957

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Skarzysko-Kamienna, Poland, 26-110

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ANTWERPEN, Belgium, 2020

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BRUXELLES - BRUSSEL, Belgium, 1070

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Coimbra, Portugal, 3030-075

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Altenburg, Germany, 04600

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Exeter, United Kingdom, EX2 5DW

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London, United Kingdom, WC1N 3BG

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Harrow, United Kingdom, HA1 3UJ

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Edinburgh, United Kingdom, EH16 4SA

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Boston, United States, 02118

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Portland, United States, 97239-3011

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Brno, Czech Republic, 656 91

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Ostrava-Poruba, Czech Republic, 708 52

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Jihlava, Czech Republic, 58633

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Vilanova de Gaia, Portugal, 4434-502

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Würzburg, Germany, 97080

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Freiburg, Germany, 79106

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Düsseldorf, Germany, 40225

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Dresden, Germany, 01307

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München, Germany, 81675

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Gloucester, United Kingdom, GL1 3NN

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Gateshead, United Kingdom, NE9 6SX

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Watford, United Kingdom, WD1 8HB

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High Wycombe, United Kingdom, HP11 2TT

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Stoke-On-Trent, United Kingdom, ST4 6QG

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Westcliff-on-Sea, United Kingdom, SS0 0RY

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Baltimore, United States, 21210

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Columbia, United States, 29203-8004

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Boston, United States, 02111

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PARIS, France, 75018

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PARIS, France, 75634

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Konskie, Poland, 26-200

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Bialystok, Poland, 15-276

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Siedlce, Poland, 08-110

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Warszawa, Poland, 00-146

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Milano, Italy, 20122

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Verona, Italy, 37126

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Vibo Valentia, Italy, 89900

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Ancona, Italy, 60126

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Pavia, Italy, 27100

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Madrid, Spain, 28046

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Madrid, Spain, 28006

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Valencia, Spain, 46026

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Barcelona, Spain, 08041

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Santiago de Compostela, Spain, 15706

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Barcelona, Spain, 08036

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HASSELT, Belgium, 3500

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EDEGEM, Belgium, 2650

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México, D.F., Mexico, 14080

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México D.F., Mexico, 06720

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Malmö, Sweden, 205 02

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Glostrup, Denmark, 2600

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Aarhus C, Denmark, 8000

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Cape Town, South Africa, 7531

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Durban, South Africa, 4100

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Somerset West, South Africa, 7130

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Olomouc, Czech Republic, 775 20

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Praha 3, Czech Republic, 10034

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Ostrava Vitkovice, Czech Republic

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Porto, Portugal, 4200-319

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Porto, Portugal, 4099-001

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Buenos Aires, Argentina, C1039AAO

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Rosario, Argentina, S2000DSV

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Banfield, Argentina, 1828

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Buenos Aires, Argentina, 1078

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Viña del Mar, Chile

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Porto Alegre, Brazil, 90110-270

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Matão, Brazil, 15990-060

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Joinville, Brazil, 89202-165

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Seoul, South Korea, 120-752

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Incheon, South Korea

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SEOUL,, South Korea, 139-872

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Donggu,, South Korea, 61469

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Goyang, South Korea, 411-706

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Seoul, South Korea, 152-703

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Anyang-si, South Korea, 431-070

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Seongnam-si, South Korea, 463-707

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Galway, Ireland

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Dublin, Ireland, DUBLIN 7

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Edmonton, Canada, T6G 2B7

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NANTES, France, 44035

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PARIS, France, 75475

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Cagliari, Italy, 09134

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Busan, South Korea, 49201

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Kitakyushu, Japan, 805-0050

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Asahikawa, Japan, 070-8530

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Fukuoka, Japan, 810-8563

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Nagoya, Japan, 454-8502

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Fukuyama, Japan, 720-0825

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Kobe, Japan, 650-0047

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Hidaka, Japan, 350-1298

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Sumida-ku, Japan, 130-8575

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Almada, Portugal, 2801-951

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Koriyama, Japan, 963-8052

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Aarau, Switzerland, 5001

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Lugano, Switzerland, 6900

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BORDEAUX, France, 33000

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Buenos Aires, Argentina, C1431FWO

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San Martín, Argentina, 1650

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Córdoba, Argentina, X5000JHQ

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Parma, Italy, 43126

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Perugia, Italy, 06024

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Aalborg, Denmark, 9100

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Budapest, Hungary, 1083

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Nyiregyhaza, Hungary, H-4400

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Eger, Hungary, 3300

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Miskolc, Hungary, 35-26

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Szeged, Hungary, 6720

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Budapest, Hungary, 1134

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Debrecen, Hungary, 4012

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Sopron, Hungary, 9400

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Turku, Finland, 20520

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Gdansk, Poland, 80-803

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Buenos Aires, Argentina, C1221 ADC

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Seoul, South Korea, 05505

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Amadora, Portugal, 2720-276

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St. Petersburg, Russia, 196247

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St. Petersburg, Russia, 190068

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Kakogawa, Japan, 675-0122

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Sendai, Japan, 982-8523

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Okazaki, Japan, 444-8553

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Kyoto, Japan, 602-8026

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Kurashiki, Japan, 710-8602

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Quebec, Canada, G1J 1Z4

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Halifax, Canada, B3H 2Y5

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Ribeirão Preto, Brazil, 14015-130

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São Paulo, Brazil, 08270-070

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OYS, Finland, 90029

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Granada, Spain, 18014

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Girona, Spain, 17007

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Barcelona, Spain, 08003

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Madrid, Spain, 28007

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Shinjuku-ku, Japan, 162-8666

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Copenhagen, Denmark, 2400

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Roma, Italy, 00168

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Isernia, Italy, 86077

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L'Aquila, Italy, 67100

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Gyor, Hungary, 9002

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Salt Lake City, United States, 84312

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Pittsburgh, United States, 15212

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Seattle, United States, 98102

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Gainesville, United States, 32611

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New Orleans, United States, 70121

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London, United Kingdom, SE5 8AF

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Norwich, United Kingdom, NR4 7UY

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Barcelona, Spain, 08035

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Kazan, Russia, 420012

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Montreal, Canada, H3G 1A4

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Lisboa, Portugal, 1198

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Zalaegerszeg, Hungary, 8900

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Seoul, South Korea, 06351

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Salvador, Brazil, 41253-190

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Rio de Janeiro, Brazil, 22281-100

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Campinas, Brazil, 13081-000

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Sandomierz, Poland

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Cáceres, Spain, 10003

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Aguascalientes, Mexico, 20127

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Kawasaki, Japan, 216-8511

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Kochi, Japan, 780-8522

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Bunkyo-ku, Japan, 113-8603

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Beijing, China, 100050

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Okayama, Japan, 700-8557

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Suita, Japan, 565-8565

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Kitakyushu, Japan, 802-8555

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Calgary, Canada, T2N 2T9

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Toronto, Canada, M4N 3M5

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Ottawa, Canada, K1Y 4E9

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Osorno, Chile

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Edmonton, Canada, T6L 5X8

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Brugge, Belgium, 8310

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Footscray, Australia, 3011

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Elizabeth Vale, Australia, 5112

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Clayton, Australia, 3168

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Camperdown, Australia, 2050

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Praha 2, Czech Republic, 128 21

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Valladolid, Spain, 47011

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Budapest, Hungary, 1204

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Luton, United Kingdom, LU4 0DZ

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Salisbury, United Kingdom, SP2 8BJ

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Aberdeen, United Kingdom, AB25 2ZN

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Cambridge, United Kingdom, CB2 0QQ

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Monterrey, Mexico, 64460

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Lodz, Poland, 90-549

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Niigata, Japan, 950-1197

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Tenri, Japan, 632-8552

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Isehara, Japan, 259-1193

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Matsubara, Japan, 580-0032

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Kobe, Japan, 654-0048

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Seto, Japan, 489-8642

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Kobe, Japan, 652-0803

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Nagoya, Japan, 457-8511

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Kyoto, Japan, 600-8558

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Musashino, Japan, 180-8610

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Kodaira, Japan, 187-8510

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Chicoutimi, Canada, G7H 5H6

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London, Canada, N6A 5A5

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Saint John, Canada, E2L 4L2

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St. Jerome, Canada, J7Z 5T3

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Vancouver, Canada, V5Z 1M9

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Victoria, Canada, V8R 1J8

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Kistarcsa, Hungary, 2143

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Ekaterinburg, Russia, 620017

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Chelyabinsk, Russia, 454021

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LE CHESNAY, France, 78150

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Rosario, Argentina

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Valdivia, Chile

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Ann Arbor, United States, 48109-0330

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New Brunswick, United States, 08901

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Wolverhampton, United Kingdom, WV10 0QP

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Great Yarmouth, United Kingdom, NR31 6LA

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Milano, Italy, 20162

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Badajoz, Spain, 06080

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Sairaalamäki, Finland, 45750

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Tampere, Finland, FIN-33520

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Yekaterinburg, Russia, 620102

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil, 14048-900

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Nagoya, Japan, 460-0001

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New Haven, United States, 06520-8064

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New York, United States, 10016-4576

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Iowa City, United States, 52242-1089

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Sasebo, Japan, 857-0134

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DENDERMONDE, Belgium, 9200

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Umeå, Sweden, 901 85

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L'Hospitalet de Llobregat, Spain, 08907

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Castellón de la Plana, Spain, 12004

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Kaluga, Russia, 248010

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Brno, Czech Republic, 625 00

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DIJON, France, 21033

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PARIS, France, 75012

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Wuppertal, Germany, 42283

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Murdoch, Australia, 6150

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Viña del Mar, Chile

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Los Angeles, Chile

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Brisbane, Australia, 4029

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Lethbridge, Canada, T1K 0C9

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Nagykanizsa, Hungary, 8800

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Yaroslavl, Russia, 150000

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Ashford, United Kingdom, TN24 0LZ

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León, Spain, 24008

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Mississauga, Canada, L5B 2V2

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Goteborg, Sweden, 413 45

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Hässleholm, Sweden, 281 25

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SAINT PRIEST EN JAREZ, France, 42270

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Santa Fe, Argentina, 3000

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Worcester, United States, 01655

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STRASBOURG, France, 67091

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Charleston, United States, 29425

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Joliet, United States, 60435

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Cleveland, United States, 44106-2602

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Blansko, Czech Republic, 67801

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Kushiro, Japan, 085-0061

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Halle, Germany, 06120

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Porto Alegre, Brazil, 90035-001

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Botucatu, Brazil, 18618 970

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Sevilla, Spain, 41009

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Waratah, Australia, 2298

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Daegu, South Korea, 41931

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Zürich, Switzerland, 8032

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Olsztyn, Poland, 10-561

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Chelm, Poland, 22-100

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Katowice, Poland, 40-635

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Changchun, China, 130021

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Houston, United States, 77030

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Montreal, Canada, H2L 4M1

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Thunder Bay, Canada, P7K 0A4

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Herlev, Denmark, 2730

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Meerbusch, Germany, 40670

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Krasnoyarsk, Russia, 660022

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Colchester, United Kingdom, CO4 5JR

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Yeovil, United Kingdom, BA21 4AT

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Sunderland, United Kingdom, SR4 7TP

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Leicester, United Kingdom, LE2 7LX

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El Palmar (Murcia), Spain, 30120

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London, Canada, N6G 2V4

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Wien, Austria, 1020

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Feldbach, Austria, 8330

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Sheffield, United Kingdom, S10 2JF

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Taunton, United Kingdom, TA1 5DA

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Durham, United Kingdom, DH1 5TW

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Tel Aviv, Israel, 6423906

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Haifa, Israel, 3339419

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Ashkelon, Israel, 7827804

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Jerusalem, Israel

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Ramat Gan, Israel, 5262000

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Salzburg, Austria, 5020

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Shanghai, China, 200032

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Shijiazhuang, China, 050000

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Changsha, China, 410008

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Tianjin, China, 300052

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Nantong, China, 226001

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Guangzhou, China, 510080

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Harbin, China

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Milton Keynes, United Kingdom, MK6 5LD

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St. Petersburg, Russia, 194354

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Tomsk, Russia, 634063

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Bern, Switzerland, 3010

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Genève, Switzerland, 1205

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Baden, Switzerland, 5404

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Vaasa, Finland, 65130

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Konya, Turkey, 42075

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Seoul, South Korea, 130-872

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Daegu, South Korea, 42415

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PARIS cedex 14, France, 75674

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CAEN CEDEX, France, 14033

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LIMOGES, France, 87042

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Ankara, Turkey, 06500

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Istanbul, Turkey, 34098

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Mannheim, Germany, 68167

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Gdansk, Poland, 80-952

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Morelia, Mexico, 58000

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Vyskov, Czech Republic, 682 01

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Hradec Kralove, Czech Republic, 500 05

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Verona, Italy, 37024

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Sevilla, Spain, 41013

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Beer Sheva, Israel, 8410101

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Haifa, Israel, 3436212

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Petah Tikva, Israel, 4941492

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Wien, Austria, 1090

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Beijing, China, 100730

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Zhengzhou, China, 450052

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ANTONY CEDEX, France, 92166

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Larissa, Greece, 41100

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Thessaloniki, Greece, 546 36

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Ioannina, Greece, 45500

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Athens, Greece, 11528

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El Paso, United States, 79905-2709

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Cleveland, United States, 44195

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Portland, United States, 97225

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Investigative Site

Stanford, United States, 94305-5119

Locations

Investigative Site

Konya, Turkey, 42080

Locations

Investigative Site

Kingston, Canada, K7L 2V7

Locations

Investigative Site

Antakya, Turkey, 31000

Locations

Investigative Site

Kahramanmaras, Turkey, 46000

Locations

Investigative Site

Ankara, Turkey, 6100

Locations

Investigative Site

Trieste, Italy, 34100

Locations

Investigative Site

Roma, Italy, 00152

Locations

Investigative Site

Roma, Italy, 00133

Locations

Investigative Site

Belo Horizonte, Brazil, 30150-221

Locations

Investigative Site

Markkleeberg, Germany, 04416

Locations

Investigative Site

Merida, Mexico, 97070

Locations

Investigative Site

Athens, Greece, 11521

Locations

Investigative Site

Torrance, United States, 90502

Locations

Investigative Site

Dallas, United States, 75390

Locations

Investigative Site

Cincinnati, United States, 45219

Locations

Investigative Site

Nashville, United States, 37232-5400

Locations

Investigative Site

Margate, United Kingdom, CT9 4AN

Locations

Investigative Site

Buffalo, United States, 14203

Locations

Investigative Site

Long Beach, United States, 90806

Locations

Investigative Site

Lexington, United States, 40536

Locations

Investigative Site

Hachioji, Japan, 192-0032

Locations

Investigative Site

Villach, Austria, 9500

Locations

Investigative Site

Vöcklabruck, Austria, 4840

Locations

Investigative Site

St. Pölten, Austria, 3100

Locations

Investigative Site

Bad Pirawarth, Austria, 2222

Locations

Investigative Site

Brandon, Canada, R7A 2B3

Locations

Investigative Site

Belo Horizonte, Brazil, 30130-100

Locations

Investigative Site

Warszawa, Poland, 03-242

Locations

Investigative Site

Delegación Gustavo A. Madero, Mexico, 07760

Locations

Investigative Site

Vila Franca de Xira, Portugal, P 2600-178

Locations

Investigative Site

Klagenfurt, Austria, 9020

Locations

Investigative Site

NIMES cedex 9, France, 30029

Locations

Investigative Site

BREST CEDEX, France, 29609

Locations

Investigative Site

Lappeenranta, Finland, FIN-53130

Locations

Investigative Site

London, United Kingdom, N18 1QX

Locations

Investigative Site

Boston, United Kingdom, PE21 9QS

Locations

Investigative Site

Hillerød, Denmark, 3400

Locations

Investigative Site

Foshan, China, 528000

Locations

Investigative Site

Kunming, China, 650032

Locations

Investigative Site

Shenyang, China, 110016

Locations

Investigative Site

Fuzhou, China, 350005

Locations

Investigative Site

Chongqing, China

Locations

Investigative Site

Hangzhou, China, 310009

Locations

Investigative Site

A Coruña, Spain, 15006

Locations

Investigative Site

Hakodate, Japan, 041-0802

Locations

Investigative Site

Nishinomiya, Japan, 663-8211

Locations

Investigative Site

Hiroshima, Japan, 730-8518

Locations

Investigative Site

Dresden, Germany, 01129

Locations

Investigative Site

Santiago, Chile, 8420524

Locations

Investigative Site

Fribourg, Switzerland, 1700

Locations

Investigative Site

Taizhou, China, 317000

Locations

Investigative Site

Baotou, China, 014010

Locations

Investigative Site

Wenzhou, China, 325000

Locations

Investigative Site

Tianjin, China, 300000

Locations

Investigative Site

Haikou, China, 570311

Locations

Investigative Site

Xi'an, China, 710038

Locations

Investigative Site

Burlington, Canada, L7M 4Y1

Locations

Investigative Site

Lleida, Spain, 25198

Locations

Investigative Site

Bilbao, Spain, 48013

Locations

Investigative Site

Austin, United States, 78701

Locations

Investigative Site

Qingdao, China, 266003

Locations

Investigative Site

Wuhan, China, 430060

Locations

Investigative Site

Feldkirch, Austria, 6807

Locations

Investigative Site

Sakai, Japan, 590-0064

Locations

Investigative Site

Fukuoka, Japan, 810-0001

Locations

Investigative Site

Fukuoka, Japan, 811-0213

Locations

Investigative Site

Lodz, Poland, 90-153

Locations

Investigative Site

Volgograd, Russia, 400131

Locations

Investigative Site

Nizhny Novgorod, Russia, 603005

Locations

Investigative Site

Kyoto, Japan, 601-1495

Locations

Investigative Site

Sant Joan Despi, Spain, 08970

Locations

Investigative Site

Toyota, Japan, 471-8513

Locations

Investigative Site

St. Petersburg, Russia, 191186

Locations

Investigative Site

Moscow, Russia, 119049

Locations

Investigative Site

Wuhan, China, 430014

Locations

Investigative Site

Wuhan, China, 430034

Locations

Investigative Site

Nanchang, China, 330006

Locations

Investigative Site

Baoji, China, 721008

Locations

Investigative Site

Zaragoza, Spain, 50009

Locations

Investigative Site

Launceston, Australia, 7250

Locations

Investigative Site

Ulyanovsk, Russia, 432063

Locations

Investigative Site

Leeds, United Kingdom, LS1 3EX

Locations

Investigative Site

Lanzhou, China, 730000

Locations

Investigative Site

Fuzhou, China, 350001

Locations

Investigative Site

Guangzhou, China

Locations

Investigative Site

Temple, United States, 76504

Locations

Investigative Site

Erie, United States, 16550

Locations

Investigative Site

Yantai, China, 264000

Locations

Investigative Site

Mount Clemens, United States, 48043

Locations

Investigative Site

Puerto Montt, Chile, 5506667

Trial Design