A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
MARINER
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
3 other identifiers
interventional
12,024
35 countries
551
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Jan 2014
Typical duration for phase_3 heart-failure
551 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
Study Start
First participant enrolled
January 7, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2018
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
November 1, 2019
4.2 years
March 31, 2014
November 5, 2019
November 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)
Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.
From randomization to 2 days after the last dose (Day 45)
Secondary Outcomes (5)
Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC
Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC
Up to Day 45
Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
Up to Day 45
Study Arms (2)
Rivaroxaban
EXPERIMENTALEach patient will receive either 10 mg or 7.5 mg rivaroxaban tablet once daily orally (by mouth) for 45 days. The dosing will depend on a creatinine clearance at screening.
Placebo
PLACEBO COMPARATOREach patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.
Interventions
Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (\>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.
Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from \>=30 to less than (\<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
Eligibility Criteria
You may qualify if:
- The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
- Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer \> 2\* upper limit of normal (ULN), or 2 with D-dimer \> 2\*ULN
You may not qualify if:
- Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
- Serious trauma (including head trauma) within 4 weeks before randomization
- History of hemorrhagic stroke at any time in the past
- Any medical condition that requires chronic use of any parenteral or oral anticoagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Bayercollaborator
Study Sites (595)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Scottsdale, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Jose, California, United States
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San Marino, California, United States
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Santa Ana, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Danbury, Connecticut, United States
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New Haven, Connecticut, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
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Bay Pines, Florida, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Celebration, Florida, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Saint Cloud, Florida, United States
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Sebring, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Normal, Illinois, United States
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North Chicago, Illinois, United States
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Hammond, Indiana, United States
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Lafayette, Indiana, United States
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Michigan City, Indiana, United States
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Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Topeka, Kansas, United States
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Alexandria, Louisiana, United States
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Lafayette, Louisiana, United States
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Metairie, Louisiana, United States
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Minden, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Rockport, Maine, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Saginaw, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Bridgeton, Missouri, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Atlantic City, New Jersey, United States
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Bridgewater, New Jersey, United States
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Marlton, New Jersey, United States
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Newark, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Jamaica, New York, United States
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Johnson City, New York, United States
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Manhasset, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Valhalla, New York, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Statesville, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Maumee, Ohio, United States
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Springfield, Ohio, United States
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Willoughby, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Abington, Pennsylvania, United States
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Camp Hill, Pennsylvania, United States
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Chambersburg, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Jefferson Hills, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Shippensburg, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Columbia, South Carolina, United States
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Summerville, South Carolina, United States
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Athens, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Channelview, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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Tyler, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Richland, Washington, United States
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Seattle, Washington, United States
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Huntington, West Virginia, United States
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La Crosse, Wisconsin, United States
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Marshfield, Wisconsin, United States
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Bahía Blanca, Argentina
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Coronel Suárez, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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Esperanza, Argentina
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La Plata, Argentina
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Merlo, Argentina
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Morón, Argentina
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Munro, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Santa Fé, Argentina
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Bedford Park, Australia
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Box Hill, Australia
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Caboolture, Australia
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Cairns, Australia
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Chermside, Australia
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East Saint Kilda, Australia
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Kogarah, Australia
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Launceston, Australia
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Lismore, Australia
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Meadowbrook, Australia
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Milton, Australia
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Nedlands, Australia
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Parkwood, Australia
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Penrith, Australia
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Redcliffe, Australia
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South Brisbane, Australia
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Sydney, Australia
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VIC, Parkville, Australia
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Feldkirch, Austria
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Graz, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Grodno, Belarus
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Homyel, Belarus
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Minsk, Belarus
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Mogilev, Belarus
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Vitebsk, Belarus
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Vychulki, Brest Region, Brest, Belarus
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Banja Luka, Bosnia and Herzegovina
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Bihać, Bosnia and Herzegovina
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Foča, Bosnia and Herzegovina
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Mostar, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
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Tuzla, Bosnia and Herzegovina
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Zenica, Bosnia and Herzegovina
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Brasília, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Brazil
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Canoas, Brazil
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Curitiba, Brazil
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Itajaí, Brazil
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Natal, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Votuporanga, Brazil
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Blagoevgrad, Bulgaria
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Gabrovo, Bulgaria
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Kozloduy, Bulgaria
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Lom, Bulgaria
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Lovech, Bulgaria
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Montana, Bulgaria
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Pernik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Razlog, Bulgaria
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Rousse, Bulgaria
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Sandanski, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Veliko Tarnovo, Bulgaria
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Vidin, Bulgaria
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Edmonton, Alberta, Canada
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Saint John, New Brunswick, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Armenia, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Cali, Colombia
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Chía, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Villavicencio, Colombia
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Čakovec, Croatia
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Karlovac, Croatia
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Krapinske Toplice, Croatia
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Osijek, Croatia
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Pula, Croatia
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Rijeka, Croatia
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Šibenik, Croatia
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Virovitica, Croatia
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Zabok, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Boskovice, Czechia
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Brno, Czechia
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Český Krumlov, Czechia
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Fryštát, Czechia
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Jablonec Na Nisou, Czechia
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Kladno, Czechia
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Krnov, Czechia
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Kyjov, Czechia
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Liberec, Czechia
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Litomyšl, Czechia
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Městec Králové, Czechia
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Nové Město na Moravě, Czechia
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Nymburk, Czechia
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Olomouc, Czechia
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Opava, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Písek, Czechia
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Prague, Czechia
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Příbram, Czechia
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Slaný, Czechia
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Sternberk, Czechia
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Svitavy, Czechia
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Teplice, Czechia
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Trutnov, Czechia
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Třinec, Czechia
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Uherské Hradiště, Czechia
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Ústí nad Labem, Czechia
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Ústí nad Orlicí, Czechia
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Zlín, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Esbjerg, Denmark
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Frederiksberg, Denmark
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Hellerup, Denmark
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Hilleroed, Denmark
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Hvidovre, Denmark
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København S, Denmark
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Roskilde, Denmark
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Tallinn, Estonia
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Batumi, Georgia
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Kutaisi, Georgia
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Marneuli, Georgia
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Rustavi, Georgia
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Tbilisi, Georgia
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Telavi, Georgia
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Berlin, Germany
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Coburg, Germany
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Dresden, Germany
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Esslingen am Neckar, Germany
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Frankfurt, Germany
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Heidelberg, Germany
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Jülich, Germany
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Karlsbad, Germany
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Leipzig, Germany
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Limburg, Germany
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Mannheim, Germany
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Minden, Germany
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Mönchengladbach, Germany
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Neuwied, Germany
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Troisdorf, Germany
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Witten, Germany
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Achaïa, Greece
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Alexandroupoli, Greece
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Athens, Greece
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Heraklion, Greece
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Ioannina, Greece
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Kifisia, Athens, Greece
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Magoula, Greece
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Pátrai, Greece
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Thessaloniki, Greece
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Thessalonikis, Greece
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Voula, Greece
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Ajka, Hungary
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Baja, Hungary
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Balassagyarmat, Hungary
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Berettyóújfalú, Hungary
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Budapest, Hungary
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Cegléd, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Farkasgyepü, Hungary
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Gödöllő, Hungary
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Gyõr, Hungary
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Gyula, Hungary
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Hódmezővásárhely, Hungary
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Kalocsa, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Keszthely, Hungary
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Kistarcsa, Hungary
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Komárom, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Orosháza, Hungary
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Pécs, Hungary
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Sátoraljaújhely, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Szentes, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Szombathely, Hungary
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Zalaegerszeg, Hungary
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Beersheba, Israel
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Hadera, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Modiin, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Rehovot, Israel
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Safed, Israel
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Tel Litwinsky, Israel
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Tiberias, Israel
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Balvi, Latvia
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Daugavpils, Latvia
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Jelgava, Latvia
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Jēkabpils, Latvia
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Krāslavas Apriņķis, Latvia
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Kuldīga, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Ventspils, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Panevezys, Lithuania
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Šiauliai, Lithuania
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Tauragė, Lithuania
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Utena, Lithuania
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Vilniaus Apskritis, Lithuania
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Vilnius, Lithuania
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Aguascalientes, Mexico
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Cuernavaca, Mexico
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Guadalajara, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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San Pedro Garza García, Mexico
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's-Hertogenbosch, Netherlands
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Alkmaar, Netherlands
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Almelo, Netherlands
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Amsterdam, Netherlands
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Arnhem, Netherlands
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Harderwijk, Netherlands
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Heerlen, Netherlands
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Hoorn, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Sittard-Geleen, Netherlands
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Sneek, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Veldhoven, Netherlands
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Zutphen, Netherlands
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Zwolle, Netherlands
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Bitola, North Macedonia
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Ohrid, North Macedonia
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Shtip, North Macedonia
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Skopje, North Macedonia
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Struga, North Macedonia
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Callao, Peru
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Lima, Peru
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Bialystok, Poland
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Bielsko-Biala, Poland
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Bydgoszcz, Poland
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Bystra, Poland
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Czeladź, Poland
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Gdynia, Poland
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Kielce, Poland
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Krakow, Poland
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Kłodzko, Poland
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Lodz, Poland
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Lublin, Poland
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Ostrołęka, Poland
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Ostrów Mazowiecka, Poland
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Oława, Poland
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Pabianice, Poland
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Poznan, Poland
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Proszowice, Poland
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Puławy, Poland
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Płock, Poland
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Rabka-Zdrój, Poland
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Siedlce, Poland
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Sopot,Gdynia, Poland
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Sosnowiec, Poland
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Szczecin, Poland
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Tarn W N/a, Poland
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Torun, Poland
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Warsaw, Poland
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Węgrów, Poland
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Wroclaw, Poland
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Łęczna, Poland
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Braga, Portugal
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Coimbra, Portugal
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Covilha, Portugal
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Figueira da Foz Municipality, Portugal
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Guimarães, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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San Juan, Puerto Rico
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Bacau, Romania
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Baia Mare, Romania
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Brasov, Romania
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Brăila, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Focşani, Romania
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Iași, Romania
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Oradea, Romania
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Piteşti, Romania
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Tg Mures, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Irkutsk, Russia
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Kazan', Russia
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Kemerovo, Russia
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Krasnodar, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Moskva, Russia
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Novosibirsk, Russia
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Orenburg, Russia
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Penza, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Smolensk, Russia
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Tomsk, Russia
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Ulyanovsk, Russia
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Vsevolzhsk, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Belgrade, Serbia
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Ćuprija, Serbia
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Čačak, Serbia
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Dedinje, Serbia
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Kamenitz, Serbia
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Kragujevac, Serbia
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Leskovac, Serbia
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Niš, Serbia
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Novi Sad, Serbia
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Smederevo, Serbia
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Subotica, Serbia
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Šabac, Serbia
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Valjevo, Serbia
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Vranje, Serbia
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Zaječar, Serbia
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Košice, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Bellville, South Africa
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Durban Kwa Zulu Natal, South Africa
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Gatesville Cape Town, South Africa
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Groenkloof, Pretoria, South Africa
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Johannesburg, South Africa
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Kempton Park, South Africa
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Kuils River, South Africa
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Pretoria, South Africa
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Somerset West, South Africa
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Stellenbosch, South Africa
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Worcester, South Africa
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Alcalá de Henares, Spain
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Alicante, Spain
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Almería, Spain
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Alzira, Spain
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Aranjuez, Spain
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Ávila, Spain
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Balea, Spain
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Barcelona, Spain
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Burgos, Spain
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Cartagena, Spain
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Cáceres, Spain
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Don Benito, Spain
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Elche, Spain
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Getafe, Spain
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Granada, Spain
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Huelva, Spain
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Las Palmas de Gran Canaria, Spain
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Logroño, Spain
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Madrid, Spain
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Majadahonda-Madrid, Spain
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Málaga, Spain
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Móstoles, Spain
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Murcia, Spain
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Olot, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Pamplona, Spain
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PAU de Sanchinarro, Spain
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Sabadell, Spain
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San Cristóbal de La Laguna, Spain
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San Sebastián de los Reyes, Spain
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Sant Boi de Llobregat, Spain
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Sant Joan d'Alacant, Spain
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Santander, Spain
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Sarrià, Spain
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Seville, Spain
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Torrelavega Cantabria, Spain
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Valencia, Spain
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Zaragoza, Spain
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Rize, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Cherkasy, Ukraine
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Chernihiv, Ukraine
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Dnipropetrovsk, Ukraine
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Ivano-Frankivsky, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomyr, Ukraine
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Angus, United Kingdom
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Cardiff, United Kingdom
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Craigavon, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Manchester, United Kingdom
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Norwich, United Kingdom
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Plymouth, United Kingdom
Related Publications (8)
Raskob GE, Spyropoulos AC, Zrubek J, Ageno W, Albers G, Elliott CG, Halperin J, Haskell L, Hiatt WR, Maynard GA, Peters G, Spiro T, Steg PG, Suh EY, Weitz JI. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016 Jun 2;115(6):1240-8. doi: 10.1160/TH15-09-0756. Epub 2016 Feb 4.
PMID: 26842902BACKGROUNDRaskob GE, Ageno W, Albers G, Elliott CG, Halperin J, Maynard G, Steg PG, Weitz JI, Albanese J, Yuan Z, Levitan B, Lu W, Suh EY, Spiro T, Lipardi C, Barnathan ES, Spyropoulos AC. Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness. J Am Heart Assoc. 2022 Oct 18;11(20):e026229. doi: 10.1161/JAHA.122.026229. Epub 2022 Oct 7.
PMID: 36205248DERIVEDSpyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.
PMID: 35389229DERIVEDRaskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.
PMID: 34755519DERIVEDJamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.
PMID: 32657973DERIVEDSpyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Lu W, Spiro TE, Barnathan ES, Raskob GE. Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients. J Am Coll Cardiol. 2020 Jun 30;75(25):3140-3147. doi: 10.1016/j.jacc.2020.04.071.
PMID: 32586587DERIVEDWeitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.
PMID: 31975354DERIVEDSpyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.
PMID: 30145946DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was stopped prior to achieving preplanned 161 participants with primary outcome events. Other limitations included how VTE-related death was defined and participants with moderate renal impairment may have been under-dosed.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 11, 2014
Study Start
January 7, 2014
Primary Completion
March 6, 2018
Study Completion
May 3, 2018
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-11