Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

Last updated: January 26, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Thrombosis

Claudication

Treatment

N/A

Clinical Study ID

NCT00440193
11702a
2006-004495-13
11702b
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion

Exclusion Criteria:

  • Legal lower age limitations (country specific)

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat thecurrent episode of DVT and/or PE

  • Other indication for VKA than DVT and/or PE

  • The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.

Study Design

Total Participants: 3449
Study Start date:
March 01, 2007
Estimated Completion Date:
April 30, 2010

Study Description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.

Connect with a study center

  • Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Lismore, New South Wales 2480
    Australia

    Site Not Available

  • St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Sydney, New South Wales 2031
    Australia

    Site Not Available

  • Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Redcliffe, Queensland 4020
    Australia

    Site Not Available

  • Southport, Queensland 4215
    Australia

    Site Not Available

  • Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Adelaide, South Australia 5042
    Australia

    Site Not Available

  • Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Clayton, Victoria 3168
    Australia

    Site Not Available

  • Geelong, Victoria 3220
    Australia

    Site Not Available

  • Melbourne, Victoria 3181
    Australia

    Site Not Available

  • Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • Perth, Western Australia 6000
    Australia

    Site Not Available

  • Graz, Steiermark 8036
    Austria

    Site Not Available

  • Feldkirch, Vorarlberg 6807
    Austria

    Site Not Available

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Salzburg, 5020
    Austria

    Site Not Available

  • Wien, 1140
    Austria

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  • Bruxelles - Brussel, 1070
    Belgium

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  • Duffel, 2570
    Belgium

    Site Not Available

  • Genk, 3600
    Belgium

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  • Gent, 9000
    Belgium

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  • Hasselt, 3500
    Belgium

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  • Leuven, 3000
    Belgium

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  • Liege, 4000
    Belgium

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  • Lier, 2500
    Belgium

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  • Namur, 5000
    Belgium

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  • Yvoir, 5530
    Belgium

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  • Zottegem, 9620
    Belgium

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  • Uberaba, Minas Gerais 38010 380
    Brazil

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  • Curitiba, Parana 80050-350
    Brazil

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  • Londrina, Parana 86038440
    Brazil

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  • Sao Paulo, SP 04023-061
    Brazil

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  • São Paulo, SP 01323-001
    Brazil

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  • Botucatu, Sao Paulo 18618 000
    Brazil

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  • Sorocaba, Sao Paulo 18031-000
    Brazil

    Site Not Available

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    São Paulo, Sao Paulo 04039-004
    Brazil

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  • Rio de Janeiro,
    Brazil

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  • Winnipeg, Manitoba R2H 2A6
    Canada

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  • London, Ontario N6A 4G5
    Canada

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  • Ottawa, Ontario K1Y 4E9
    Canada

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  • Toronto, Ontario M4N 3M5
    Canada

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  • Guangzhou, Guangdong 510000
    China

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  • Harbin, Heilongjiang 150086
    China

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  • Wuhan, Hubei 430022
    China

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  • Suzhou, Jiangsu 215004
    China

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  • Shenyang, Liaoning 110016
    China

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  • Hangzhou, Zhejiang 310016
    China

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  • Beijing, 100037
    China

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  • Shanghai, 200032
    China

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  • Karlovy Vary, 360 00
    Czech Republic

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  • Kladno, 27259
    Czech Republic

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  • Ostrava, 728 80
    Czech Republic

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  • Ostrava-Poruba, 708 52
    Czech Republic

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  • Prague, 140 21
    Czech Republic

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  • Prague 5, 150 00
    Czech Republic

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  • Praha 1, 110 00
    Czech Republic

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  • Praha 2, 12800
    Czech Republic

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  • Usti nad Lebem, 401 13
    Czech Republic

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  • Aarhus C, 8000
    Denmark

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  • Braedstrup, 8740
    Denmark

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  • Frederiksberg, 2000F
    Denmark

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  • Hellerup, 2900
    Denmark

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  • empty

    Seinäjoki, 60220
    Finland

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  • Seinäjoki, 60220
    Finland

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  • Agen Cedex 9, 47923
    France

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  • Amiens, 80000
    France

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  • Angers Cedex 01, 49033
    France

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  • Arras, 62000
    France

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  • Besancon, 25000
    France

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  • Bordeaux, 33000
    France

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  • Brest Cedex, 29609
    France

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  • Castelnau Le Lez, 34170
    France

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  • Clamart, 92141
    France

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  • Clermont Ferrand, 63000
    France

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  • Colombes Cedex, 92701
    France

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  • Creteil, 94000
    France

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  • Dijon, 21000
    France

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  • Grenoble, 38028
    France

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  • Lille Cedex, 59037
    France

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  • Limoges, 87042
    France

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  • Metz-tessy, 74370
    France

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  • Montpellier Cedex, 34295
    France

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  • Nantes, 44000
    France

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  • Nice, 06002
    France

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  • Nimes Cedex 9, 30029
    France

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  • Orthez, 64300
    France

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  • Paris, 75877
    France

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  • Paris Cedex 15, 75908
    France

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  • Pierre Benite, 69495
    France

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  • Roanne, 42328
    France

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  • Rouen Cedex, 76031
    France

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  • Saint Etienne, 42055
    France

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  • Strasbourg Cedex, 67091
    France

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  • Toulon, 83000
    France

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  • Toulouse, 31403
    France

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  • Tours, 37044
    France

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  • Valenciennes Cedex, 59322
    France

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  • Vandoeuvre Les Nancy, 54511
    France

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  • Vernon, 27200
    France

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    Neckargemünd, Baden-Württemberg 69151
    Germany

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    Tübingen, Baden-Württemberg 72076
    Germany

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  • Bruchsal, Baden-Württemberg 76646
    Germany

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  • Heidelberg, Baden-Württemberg 69115
    Germany

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  • Karlsbad, Baden-Württemberg 76307
    Germany

    Site Not Available

  • Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Neckargemünd, Baden-Württemberg 69151
    Germany

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  • Tübingen, Baden-Württemberg 72076
    Germany

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  • Augsburg, Bayern 86156
    Germany

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  • empty

    München, Bayern 81377
    Germany

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  • München, Bayern 81377
    Germany

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  • empty

    Würzburg, Bayern 97080
    Germany

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  • Würzburg, Bayern 97080
    Germany

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  • Darmstadt, Hessen 64297
    Germany

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  • Frankfurt, Hessen 60590
    Germany

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    Gießen, Hessen 35392
    Germany

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  • Gießen, Hessen 35392
    Germany

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  • Wiesbaden, Hessen 65183
    Germany

    Site Not Available

  • Greifswald, Mecklenburg-Vorpommern 17475
    Germany

    Site Not Available

  • Hannover, Niedersachsen 30625
    Germany

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  • Rotenburg, Niedersachsen 27342
    Germany

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  • empty

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

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  • Düsseldorf, Nordrhein-Westfalen 40225
    Germany

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  • Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Paderborn, Nordrhein-Westfalen 33098
    Germany

    Site Not Available

  • Soest, Nordrhein-Westfalen 59494
    Germany

    Site Not Available

  • Witten, Nordrhein-Westfalen 58455
    Germany

    Site Not Available

  • Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Homburg, Saarland 66424
    Germany

    Site Not Available

  • Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Leipzig, Sachsen 04289
    Germany

    Site Not Available

  • Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • Magdeburg, Sachsen-Anhalt 39112
    Germany

    Site Not Available

  • Berlin, 10713
    Germany

    Site Not Available

  • Hamburg, 20251
    Germany

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Wanchai,
    Hong Kong

    Site Not Available

  • Budapest, 1115
    Hungary

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  • Debrecen, 4032
    Hungary

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  • Kecskemet, 6000
    Hungary

    Site Not Available

  • Kistarcsa, 2143
    Hungary

    Site Not Available

  • Miskolc, 3526
    Hungary

    Site Not Available

  • Szentes, 6600
    Hungary

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  • Szombathely, 9700
    Hungary

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  • Kochi, Kerala 682026
    India

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  • Mumbai, Maharashtra 400016
    India

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  • Hyderabad, 500082
    India

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  • Kolkata, 700029
    India

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  • New Delhi, 110060
    India

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  • Pune, 411001
    India

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  • Bandung, 40161
    Indonesia

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  • Jakarta, 10430
    Indonesia

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  • Medan, 20152
    Indonesia

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  • Semarang, 50241
    Indonesia

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  • Afula, 18101
    Israel

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  • Ashkelon, 78306
    Israel

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  • Beer Sheva, 84101
    Israel

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  • Haifa, 34362
    Israel

    Site Not Available

  • Holon, 58100
    Israel

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  • Jerusalem, 91120
    Israel

    Site Not Available

  • Kfar Saba, 44281
    Israel

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  • Petach Tikva, 49100
    Israel

    Site Not Available

  • Rehovot, 76100
    Israel

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  • Safed, 13100
    Israel

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  • Tel Aviv, 64239
    Israel

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  • Bologna, 40138
    Italy

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  • Chieti, 66013
    Italy

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  • Cremona, 26100
    Italy

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  • Milano, 20132
    Italy

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  • Napoli, 80131
    Italy

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  • Padova, 35128
    Italy

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  • Palermo, 90127
    Italy

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  • Parma, 43100
    Italy

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  • Pavia, 27100
    Italy

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  • Piacenza, 29100
    Italy

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  • Reggio Emilia, 42100
    Italy

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  • Varese, 21100
    Italy

    Site Not Available

  • Venezia, 30122
    Italy

    Site Not Available

  • Daegu, 705-718
    Korea, Republic of

    Site Not Available

  • Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Taegu, 700-712
    Korea, Republic of

    Site Not Available

  • Selangor, 68000
    Malaysia

    Site Not Available

  • Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Enschede, 7511 JX
    Netherlands

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  • Groningen, 9713 GZ
    Netherlands

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  • Hoofddorp, 2134 TM
    Netherlands

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  • Maastricht, 6229 HX
    Netherlands

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  • Rotterdam, 3083 AN
    Netherlands

    Site Not Available

  • Zwijndrecht, 3331 LZ
    Netherlands

    Site Not Available

  • Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Auckland, 2024
    New Zealand

    Site Not Available

  • Christchurch, 8011
    New Zealand

    Site Not Available

  • Palmerston North, 4414
    New Zealand

    Site Not Available

  • Wellington South, 6021
    New Zealand

    Site Not Available

  • Fredrikstad, 1603
    Norway

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  • Oslo, 0407
    Norway

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  • Rud, 1309
    Norway

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  • Trondheim, 7006
    Norway

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  • Quezon City, 1102
    Philippines

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  • Bialystok, 15-276
    Poland

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  • Bydgoszcz, 85-168
    Poland

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  • Gdansk, 80-952
    Poland

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  • Katowice, 40-365
    Poland

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  • Krakow, 31-066
    Poland

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  • Lodz, 90-153
    Poland

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  • Lublin, 20-081
    Poland

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  • Poznan, 61-848
    Poland

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  • Torun, 87-100
    Poland

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  • Warszawa, 02-097
    Poland

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  • Wroclaw, 50-326
    Poland

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  • San Juan, 00927
    Puerto Rico

    Site Not Available

  • Singapore, 308433
    Singapore

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  • Johannesburg, Gauteng 2157
    South Africa

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  • Pretoria, Gauteng 0157
    South Africa

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  • Cape Town, Western Cape 7460
    South Africa

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  • Somerset West, Western Cape 7130
    South Africa

    Site Not Available

  • Worcester, Western Cape 6850
    South Africa

    Site Not Available

  • Terrassa, Barcelona 08221
    Spain

    Site Not Available

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    Alcorcón, Madrid 28922
    Spain

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  • Alcorcón, Madrid 28922
    Spain

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  • Fuenlabrada, Madrid 28942
    Spain

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    Xàtiva, Valencia 46800
    Spain

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  • Xàtiva, Valencia 46800
    Spain

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  • Barcelona, 08025
    Spain

    Site Not Available

  • Girona, 17007
    Spain

    Site Not Available

  • Madrid, 28034
    Spain

    Site Not Available

  • Pamplona, 31008
    Spain

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  • empty

    Borås, 501 82
    Sweden

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  • Borås, 501 82
    Sweden

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  • empty

    Göteborg, 413 45
    Sweden

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  • Göteborg, 413 45
    Sweden

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  • empty

    Jönköping, 551 85
    Sweden

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  • Jönköping, 551 85
    Sweden

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  • Sundsvall, 851 86
    Sweden

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    Västervik, 593 81
    Sweden

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  • Västervik, 593 81
    Sweden

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  • empty

    Genéve 14, Genève 14 1211
    Switzerland

    Site Not Available

  • Genéve 14, Genève 14 1211
    Switzerland

    Site Not Available

  • Chur, Graubünden 7000
    Switzerland

    Site Not Available

  • Lausanne, Waadt 1005
    Switzerland

    Site Not Available

  • Luzern, 6000
    Switzerland

    Site Not Available

  • empty

    Zürich, 8091
    Switzerland

    Site Not Available

  • Zürich, 8091
    Switzerland

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  • Kaosiung, Kaoshiong 807
    Taiwan

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  • Taichung, 40705
    Taiwan

    Site Not Available

  • Taipei, 10016
    Taiwan

    Site Not Available

  • Bangkok, 10400
    Thailand

    Site Not Available

  • Pathumwan, Bangkok, 10330
    Thailand

    Site Not Available

  • Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • Chelmsford, Essex CM1 5ET
    United Kingdom

    Site Not Available

  • Isleworth, Greater London TW7 6AF
    United Kingdom

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  • London,
    United Kingdom

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  • Little Rock, Arkansas 72205
    United States

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  • Redlands, California 92373
    United States

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  • Bay Pines, Florida 33744
    United States

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  • Miami, Florida 33136-1096
    United States

    Site Not Available

  • Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Covington, Louisiana 70433
    United States

    Site Not Available

  • Baltimore, Maryland 21215
    United States

    Site Not Available

  • Boston, Massachusetts 02215
    United States

    Site Not Available

  • Albuquerque, New Mexico 87108-4763
    United States

    Site Not Available

  • Chapel Hill, North Carolina 27599-7035
    United States

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  • Greensboro, North Carolina 27403
    United States

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  • Oklahoma City, Oklahoma 73104
    United States

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  • Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15224
    United States

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  • Corsicana, Texas 75110
    United States

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  • San Antonio, Texas 78229
    United States

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  • Murray, Utah 84157
    United States

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  • Salt Lake City, Utah 84132
    United States

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  • Fredericksburg, Virginia 22401
    United States

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  • Spokane, Washington 99204
    United States

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  • Tacoma, Washington 98405
    United States

    Site Not Available

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