Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
VOYAGER PAD
An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures
2 other identifiers
interventional
6,564
32 countries
517
Brief Summary
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Typical duration for phase_3
517 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedStudy Start
First participant enrolled
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2020
CompletedResults Posted
Study results publicly available
December 8, 2020
CompletedDecember 8, 2020
December 1, 2020
4.3 years
July 20, 2015
November 9, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.
Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
Secondary Outcomes (9)
Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology
For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.
Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)
For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.
Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature
For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days
Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology
For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days
Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology
For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days
- +4 more secondary outcomes
Study Arms (2)
Rivaroxaban
EXPERIMENTALRivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)
Placebo
PLACEBO COMPARATORRivaroxaban-placebo orally twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥50
- Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
- Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization
You may not qualify if:
- Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
- Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
- Prior revascularization on the index leg within 10 days of the qualifying revascularization.
- Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for \>6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
- Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
- Colorado Prevention Centercollaborator
Study Sites (532)
Unknown Facility
Alexander City, Alabama, 35010, United States
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Birmingham, Alabama, 35294-0012, United States
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Fort Payne, Alabama, 35967, United States
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Huntsville, Alabama, 35801-4317, United States
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Avondale, Arizona, 85388, United States
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Glendale, Arizona, 85340, United States
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Phoenix, Arizona, 85006, United States
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Mission Viejo, California, 92691, United States
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Northridge, California, 91325, United States
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Palo Alto, California, 94304, United States
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Roseville, California, 95661, United States
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Stanford, California, 94305, United States
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Torrance, California, 90502, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80220, United States
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Washington D.C., District of Columbia, 20007, United States
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Washington D.C., District of Columbia, 20422, United States
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Atlantis, Florida, 33462, United States
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Clearwater, Florida, 33756, United States
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Daytona Beach, Florida, 32117, United States
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Gainesville, Florida, 32605, United States
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Hudson, Florida, 34667, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33173, United States
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Ocala, Florida, 34474, United States
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Pensacola, Florida, 32501, United States
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Safety Harbor, Florida, 34695, United States
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Tallahassee, Florida, 32308, United States
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Wellington, Florida, 33449, United States
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Arlington Heights, Illinois, 60005, United States
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Elk Grove Village, Illinois, 60007, United States
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Springfield, Illinois, 62701, United States
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Springfield, Illinois, 62702, United States
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Urbana, Illinois, 61801, United States
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Fort Wayne, Indiana, 46804, United States
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Fort Wayne, Indiana, 46845, United States
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Merrillville, Indiana, 46410, United States
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Iowa City, Iowa, 52242, United States
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Lexington, Kentucky, 40536, United States
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Alexandria, Louisiana, 71301, United States
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Covington, Louisiana, 70433, United States
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Shreveport, Louisiana, 71103, United States
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Shreveport, Louisiana, 71105, United States
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Lewiston, Maine, 04240, United States
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Baltimore, Maryland, 21201-1595, United States
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Baltimore, Maryland, 21218, United States
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Clinton, Maryland, 20735, United States
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Bay City, Michigan, 48708, United States
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Dearborn, Michigan, 48126, United States
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Detroit, Michigan, 48201, United States
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Lansing, Michigan, 48912, United States
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Midland, Michigan, 48670, United States
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Muskegon, Michigan, 49444, United States
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Wyoming, Michigan, 49519, United States
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Coon Rapids, Minnesota, 55433, United States
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Saint Cloud, Minnesota, 56303, United States
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Jackson, Mississippi, 39216, United States
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Tupelo, Mississippi, 38801, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63128, United States
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Lincoln, Nebraska, 68506, United States
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Lincoln, Nebraska, 68510, United States
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Lebanon, New Hampshire, 03756-0001, United States
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Flemington, New Jersey, 08822, United States
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Linden, New Jersey, 07036, United States
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Teaneck, New Jersey, 07666, United States
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New York, New York, 10011, United States
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New York, New York, 10029, United States
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Saratoga Springs, New York, 12866, United States
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Chapel Hill, North Carolina, 27517, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Winston-Salem, North Carolina, 27103, United States
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Minot, North Dakota, 58701, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Dayton, Ohio, 45414, United States
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Springfield, Ohio, 45505, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73135, United States
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Hillsboro, Oregon, 97123, United States
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Camp Hill, Pennsylvania, 17011, United States
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Erie, Pennsylvania, 16507, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19140, United States
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York, Pennsylvania, 17405, United States
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Greenville, South Carolina, 29657, United States
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Rapid City, South Dakota, 57702, United States
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Knoxville, Tennessee, 37934, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75216-7167, United States
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Dallas, Texas, 75226, United States
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Edinburg, Texas, 78539, United States
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Houston, Texas, 77030, United States
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Humble, Texas, 77338, United States
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Huntsville, Texas, 77340, United States
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Kingwood, Texas, 77339, United States
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San Antonio, Texas, 78258, United States
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Tyler, Texas, 75701, United States
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Victoria, Texas, 77901, United States
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Madison, Wisconsin, 53713, United States
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Manitowoc, Wisconsin, 54220, United States
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Wausau, Wisconsin, 54401, United States
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Bahía Blanca, Buenos Aires, B8001HXM, Argentina
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Ciudadela, Buenos Aires, 1702, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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Junín, Buenos Aires, B6000BHA, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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La Plata, Buenos Aires, B1900ASM, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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San Isidro, Buenos Aires, B1642DCD, Argentina
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San Martín, Buenos Aires, 1650, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, 1078, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1119ACN, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART, Argentina
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Santa Rosa, La Pampa Province, 6300, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000PBJ, Argentina
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Rosario, Santa Fe Province, S2000QID, Argentina
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Ciudad Auton. de Buenos Aires, C1181ACL, Argentina
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Corrientes, 3400, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5006IKK, Argentina
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Santa Fe, S3000FWO, Argentina
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Klagenfurt, Carinthia, 9020, Austria
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Feldkirch, Vorarlberg, 6807, Austria
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Linz, 4021, Austria
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Vienna, 1090, Austria
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Vienna, 1140, Austria
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Vienna, 1160, Austria
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Vienna, 1170, Austria
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Bruxelles - Brussel, 1070, Belgium
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Bruxelles - Brussel, 1090, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Fortaleza, Ceará, 60430 370, Brazil
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Belo Horizonte, Minas Gerais, 30110-090, Brazil
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Belo Horizonte, Minas Gerais, 30130-100, Brazil
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Belo Horizonte, Minas Gerais, 30140-062, Brazil
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Belo Horizonte, Minas Gerais, 30140-073, Brazil
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Uberlândia, Minas Gerais, 38411-186, Brazil
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Curitiba, Paraná, 80230-130, Brazil
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Canoas, Rio Grande do Sul, 92200-000, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
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Porto Alegre, Rio Grande do Sul, 90619900, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Belo Horizonte, São Paulo, 30110-130, Brazil
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Campinas, São Paulo, 13060-080, Brazil
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Santo André, São Paulo, 09030-010, Brazil
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São Bernardo do Campo, São Paulo, 09715-090, Brazil
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São José do Rio Preto, São Paulo, 15090, Brazil
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São Paulo, São Paulo, 01323-903, Brazil
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Tatuí, São Paulo, 18270-170, Brazil
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Rio de Janeiro, 20551-030, Brazil
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Burgas, 8000, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7002, Bulgaria
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Rousse, 7013, Bulgaria
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Samokov, 2000, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9010, Bulgaria
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Yambol, 8600, Bulgaria
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Winnipeg, Manitoba, R2H 2A6, Canada
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St. John's, Newfoundland and Labrador, A1C 2H6, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, ON N6A 5W9, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Gatineau, Quebec, J8Y 6S8, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, G1L 3L5, Canada
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Vancouver, V5Z 1M9, Canada
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Hefei, Anhui, 230001, China
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Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, 350025, China
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Zhangzhou, Fujian, 363000, China
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510630, China
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Guangzhou, Guangdong, China
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Zhanjiang, Guangdong, 524001, China
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Zhongshan, Guangdong, 528403, China
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Haikou, Hainan, 570311, China
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Wuhan, Hubei, 430014, China
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Wuhan, Hubei, 430030, China
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Changsha, Hunan, 410008, China
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Changsha, Hunan, 410011, China
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Changzhou, Jiangsu, 213003, China
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Nanjing, Jiangsu, 210006, China
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Changchun, Jilin, 130021, China
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Xi'an, Shaanxi, 710038, China
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Qingdao, Shandong, 266003, China
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Taiyuan, Shanxi, 030001, China
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Taizhou, Zhejiang, 317000, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100029, China
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Beijing, 100053, China
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Beijing, 100083, China
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Beijing, 100144, China
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Beijing, 100730, China
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Beijing, 100853, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Tianjin, 300000, China
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Brno, 656 91, Czechia
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Hodonín, 69501, Czechia
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Hradec Králové, 500 05, Czechia
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Kladno, 27259, Czechia
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Liberec, 460 63, Czechia
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Olomouc, 775 20, Czechia
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Pilsen, 30599, Czechia
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Prague, 10100, Czechia
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Prague, 12808, Czechia
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Prague, 150 06, Czechia
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Prague, 15006, Czechia
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Prostějov, 798 11, Czechia
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Vratimov, 73932, Czechia
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Aarhus N, 8200, Denmark
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Kolding, 6000, Denmark
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København Ø, 2100, Denmark
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Odense C, 5000, Denmark
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Viborg, 8800, Denmark
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Tallinn, 11312, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50406, Estonia
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Helsinki, 00290, Finland
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Oulu, 90220, Finland
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Tampere, 33521, Finland
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Bordeaux, 33000, France
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Bordeaux, 33075, France
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Caen, 14033, France
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Castelnau-le-Lez, 34170, France
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Grenoble, 38043, France
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Le Coudray, 28630, France
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Limoges, 87042, France
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Montpellier, 34295, France
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Nice, 06280, France
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Paris, 75634, France
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Paris, 75908, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Strasbourg, 67091, France
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Toulouse, 31300, France
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Toulouse, 31403, France
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Bad Friedrichshall, Baden-Wurttemberg, 74177, Germany
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Bad Krozingen, Baden-Wurttemberg, 79189, Germany
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Freudenstadt, Baden-Wurttemberg, 72250, Germany
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Heidelberg, Baden-Wurttemberg, 69129, Germany
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Karlsbad, Baden-Wurttemberg, 76307, Germany
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Karlsruhe, Baden-Wurttemberg, 76133, Germany
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Ulm, Baden-Wurttemberg, 89081, Germany
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Erlangen, Bavaria, 91054, Germany
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Immenstadt im Allgäu, Bavaria, 87509, Germany
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München, Bavaria, 80331, Germany
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München, Bavaria, 80336, Germany
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München, Bavaria, 81675, Germany
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Regensburg, Bavaria, 93053, Germany
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Rosenheim, Bavaria, 83022, Germany
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Bad Nauheim, Hesse, 61231, Germany
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Darmstadt, Hesse, 64276, Germany
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Frankfurt am Main, Hesse, 60389, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Frankfurt am Main, Hesse, 65929, Germany
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Arnsberg, North Rhine-Westphalia, 59759, Germany
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Bielefeld, North Rhine-Westphalia, 33604, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Krefeld, North Rhine-Westphalia, 47805, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Wesel, North Rhine-Westphalia, 46483, Germany
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Kaiserslautern, Rhineland-Palatinate, 67657, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 01099, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04103, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Lübeck, Schleswig-Holstein, 23538, Germany
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Jena, Thuringia, 07740, Germany
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Sonneberg, Thuringia, 96515, Germany
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Berlin, 10713, Germany
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Berlin, 10787, Germany
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Bremen, 28277, Germany
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Dresden, 01067, Germany
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Hamburg, 20246, Germany
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Budapest, 1085, Hungary
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Budapest, 1106, Hungary
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Budapest, 1115, Hungary
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Debrecen, 4032, Hungary
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Győr, 9023, Hungary
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Kaposvár, 7400, Hungary
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Kistarcsa, 2143, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7624, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, 8000, Hungary
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Szombathely, 9700, Hungary
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Lecce, Apulia, 73100, Italy
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Potenza, Basilicate, 85100, Italy
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Avellino, Campania, 83100, Italy
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Ravenna, Emilia-Romagna, 48033, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Rome, Lazio, 00161, Italy
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Milan, Lombardy, 20132, Italy
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Varese, Lombardy, 21100, Italy
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Turin, Piedmont, 10126, Italy
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Palermo, Sicily, 90127, Italy
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Ragusa, Sicily, 97100, Italy
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Macerata, The Marches, 62100, Italy
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Florence, Tuscany, 50134, Italy
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Perugia, Umbria, 06132, Italy
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Nagakute, Aichi-ken, 480-1195, Japan
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Matsuyama, Ehime, 790-8524, Japan
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Kitakyushu, Fukuoka, 802-8555, Japan
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Kitakyushu, Fukuoka, 805-0050, Japan
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Kurume, Fukuoka, 830-8577, Japan
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Shibukawa, Gunma, 377-0061, Japan
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Hatsukaichi, Hiroshima, 738-8503, Japan
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Asahikwa, Hokkaido, 078-8510, Japan
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Sapporo, Hokkaido, 060-0031, Japan
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Sapporo, Hokkaido, 064-8622, Japan
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Tomakomai, Hokkaido, 053-8506, Japan
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Amagasaki, Hyōgo, 660-8511, Japan
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Himeji, Hyōgo, 670-0981, Japan
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Himeji, Hyōgo, 671-1227, Japan
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Kobe, Hyōgo, 650-0047, Japan
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Kobe, Hyōgo, 651-0053, Japan
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Takarazuka, Hyōgo, 665-0873, Japan
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Morioka, Iwate, 020-0066, Japan
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Takamatsu, Kagawa-ken, 760-8557, Japan
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Kawasaki, Kanagawa, 215-0026, Japan
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Sagamihara, Kanagawa, 252-5188, Japan
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Matsusaka, Mie-ken, 515-8566, Japan
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Matsumoto, Nagano, 390-8621, Japan
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Kashihara, Nara, 634-8522, Japan
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Beppu, Oita Prefecture, 874-0011, Japan
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Habikino, Osaka, 583-0872, Japan
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Kawagoe, Saitama, 350-8550, Japan
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Ōmihachiman, Shiga, 523-0082, Japan
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Hamada, Shimane, 697-8511, Japan
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Bunkyo-ku, Tokyo, 113-8519, Japan
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Fuchū, Tokyo, 183-0003, Japan
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Itabashi-ku, Tokyo, 173-0015, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Meguro-ku, Tokyo, 152-8902, Japan
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Minato, Tokyo, 108-0073, Japan
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Minato-ku, Tokyo, 108-8329, Japan
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Suginami-ku, Tokyo, 166-0001, Japan
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Gifu, 500-8717, Japan
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Kagoshima, 890-8760, Japan
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Kumamoto, 860-0008, Japan
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Kyoto, 604-8401, Japan
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Kyoto, 615-8256, Japan
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Miyazaki, 880-2102, Japan
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Osaka, 530-0012, Japan
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Osaka, 530-8480, Japan
Unknown Facility
Osaka, 558-8558, Japan
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Saitama, 336-8522, Japan
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Shizuoka, 420-8630, Japan
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Daugavpils, LV-5417, Latvia
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Liepāja, LV-3414, Latvia
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Riga, 1038, Latvia
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Riga, LV-1002, Latvia
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Kaunas, 45130, Lithuania
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Kaunas, LT-50009, Lithuania
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Panevezys, 35144, Lithuania
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Vilnius, LT-08661, Lithuania
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Vilnius, LT-10207, Lithuania
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's-Hertogenbosch, 5223 GZ, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Enschede, 7611 JH, Netherlands
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Heerlen, 6419 PC, Netherlands
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Utrecht, 3584 CX, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Zwolle, 8025 AB, Netherlands
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Bialystok, 15_111, Poland
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Bydgoszcz, 85-094, Poland
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Gdynia, 81-338, Poland
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Katowice, 40-040, Poland
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Krakow, Poland
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Lodz, 94-048, Poland
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Lublin, 20-044, Poland
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Lublin, 20-718, Poland
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Poznan, 61-848, Poland
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Szczecin, 70-111, Poland
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Warsaw, 01-211, Poland
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Warsaw, 01-868, Poland
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Warsaw, 02-097, Poland
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Wroclaw, 50-981, Poland
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Almada, Setúbal District, 2805-267, Portugal
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Lisbon, 1169-1024, Portugal
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Ponta Delgada, 9500-370, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-319, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
Unknown Facility
Piteşti, Argeş, 110084, Romania
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Bucharest, 010192, Romania
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Bucharest, 011461, Romania
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Bucharest, 022322, Romania
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Cluj-Napoca, 400001, Romania
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Iași, 700732, Romania
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Oradea, Romania
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Târgu Mureş, 540124, Romania
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Timișoara, 300736, Romania
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Kemerovo, 650002, Russia
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Moscow, 105077, Russia
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Moscow, 115682, Russia
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Moscow, 117997, Russia
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Moscow, 129327, Russia
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Nizhny Novgorod, 603155, Russia
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Novosibirsk, 630055, Russia
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Novosibirsk, 630087, Russia
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Rostov-on-Don, 344022, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197374, Russia
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Tomsk, 634012, Russia
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Tver', 170036, Russia
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Voronezh, 394066, Russia
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Belgrade, 11000, Serbia
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Belgrade, 11040, Serbia
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Belgrade, 11080, Serbia
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Niš, 18000, Serbia
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Bardejov, 085 01, Slovakia
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Bratislava, 833 48, Slovakia
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Bratislava, 83348, Slovakia
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Bratislava, 851 07, Slovakia
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Dunajská Streda, 92901, Slovakia
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Košice, 04001, Slovakia
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Nitra, 949 01, Slovakia
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Nové Zámky, 940 01, Slovakia
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Trnava, 91701, Slovakia
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Žilina, 01001, Slovakia
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Goyang-si, Gyeonggido, 10326, South Korea
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Seongnam-si, Gyeonggido, 13620, South Korea
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Incheon, Incheon Gwang''yeogsi, 21565, South Korea
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Busan, 49201, South Korea
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Daegu, 42472, South Korea
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Daegu, 700-712, South Korea
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Daejeon, 301-723, South Korea
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Jung-gu Daejeon, 35015, South Korea
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Seoul, 03722, South Korea
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Seoul, 05368, South Korea
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Seoul, 06351, South Korea
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Seoul, 137-701, South Korea
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Seoul, 152-703, South Korea
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Seoul, South Korea
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Cadiz, Andalusia, 11009, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Sabadell, Barcelona, 08208, Spain
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A Coruña, 15006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Ciudad Real, 13005, Spain
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Granada, 18012, Spain
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Madrid, 28006, Spain
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Pamplona, 31008, Spain
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Tarragona, 43005, Spain
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Gothenburg, 413 46, Sweden
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Linköping, 582 85, Sweden
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Malmo, 205 02, Sweden
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Solna, 171 76, Sweden
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Vaxjo, 351 85, Sweden
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Basel, Canton of Basel-City, 4031, Switzerland
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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
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Chur, Kanton Graubünden, 7000, Switzerland
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Baden, 5404, Switzerland
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Bern, 3010, Switzerland
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Fribourg, 1700, Switzerland
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Geneva, 1205, Switzerland
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Lucerne, 6000, Switzerland
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Hsinchu, 300, Taiwan
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Kaohsiung City, 813, Taiwan
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Kaohsiung City, 82445, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 333423, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Bangkok, Thailand
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Khon Kaen, 40002, Thailand
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Songkhla, 90110, Thailand
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Dnipro, 49000, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Ivano-Frankivsk, 76014, Ukraine
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Kharkiv, 61018, Ukraine
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Kiev, 3680, Ukraine
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Kyiv, 1601, Ukraine
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Lviv, 79010, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhya, 69600, Ukraine
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Carlisle, Cumbria, CA2 7HY, United Kingdom
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Hull, Humberside, HU3 2JZ, United Kingdom
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Harrow, London, HA1 3UJ, United Kingdom
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Doncaster, South Yorkshire, DN2 5LT, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
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Birmingham, West Midlands, B9 5SS, United Kingdom
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Leeds, West Yorkshire, LS1 3EX, United Kingdom
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Worcester, Worcestershire, WR5 1DD, United Kingdom
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Cambridge, CB3 OLB, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW17 0QT, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Sheffield, S5 7AU, United Kingdom
Related Publications (12)
Hogan S, Szarek M, Debus ES, Nehler M, Anand SS, Patel MR, Pap AF, Deng H, Hodge S, Haskell LP, Muehlhofer E, Berkowitz SE, Bauersachs RM, Bonaca MP. Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD. J Am Heart Assoc. 2025 Nov 4;14(21):e039752. doi: 10.1161/JAHA.124.039752. Epub 2025 Oct 23.
PMID: 41128134DERIVEDRogers RK, Herold J, Govsyeyev N, Iezzi R, Morrison J, Hogan SE, Nehler M, Bricker R, Andring B, Bergmark B, Cavender M, Malgor E, Jacobs D, Young MN, Capell W, Ycas JW, Anand SS, Berkowitz SD, Debus ES, Haskell LP, Muehlhofer E, Patel MR, Hess CN, Bauersachs RM, Anderson V, Bonaca MP. Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD. Vasc Med. 2024 Apr;29(2):143-152. doi: 10.1177/1358863X241228542. Epub 2024 Mar 17.
PMID: 38493348DERIVEDHogan SE, Debus ES, Nehler MR, Patel MR, Anand SS, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Unplanned Index Limb Revascularization With Rivaroxaban Versus Placebo in Patients With Critical Limb-Threatening Ischemia After Endovascular and Surgical Treatment: Insights From VOYAGER PAD. Circulation. 2024 Feb 20;149(8):635-637. doi: 10.1161/CIRCULATIONAHA.123.065330. Epub 2024 Feb 20. No abstract available.
PMID: 38377256DERIVEDGovsyeyev N, Nehler M, Conte MS, Debus S, Chung J, Dorigo W, Gudz I, Krievins D, Mills J, Moll F, Norgren L, Piffaretti G, Powell R, Szalay D, Sillesen H, Wohlauer M, Szarek M, Bauersachs RM, Anand SS, Patel MR, Capell WH, Jaeger N, Hess CN, Muehlhofer E, Haskell LP, Berkowitz SD, Bonaca MP. Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits. J Vasc Surg. 2023 Apr;77(4):1107-1118.e2. doi: 10.1016/j.jvs.2022.11.062. Epub 2022 Dec 5.
PMID: 36470531DERIVEDHess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.
PMID: 35699170DERIVEDHogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.
PMID: 35467452DERIVEDHess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.
PMID: 34711335DERIVEDDebus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.
PMID: 34380322DERIVEDBauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.
PMID: 34010631DERIVEDHiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.
PMID: 33138628DERIVEDBonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.
PMID: 32222135DERIVEDCapell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.
PMID: 29754671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 21, 2015
Study Start
August 18, 2015
Primary Completion
November 27, 2019
Study Completion
January 9, 2020
Last Updated
December 8, 2020
Results First Posted
December 8, 2020
Record last verified: 2020-12