A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

NCT ID: NCT02111564

Last Updated: 2019-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12024 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-07

Study Completion Date

2018-05-03

Brief Summary

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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.

Detailed Description

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This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.

Conditions

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Heart Failure Respiratory Insufficiency Stroke Acute Infectious Diseases Rheumatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Rivaroxaban

Each 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.

Group Type EXPERIMENTAL

Rivaroxaban, 10 mg

Intervention Type DRUG

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.

Rivaroxaban, 7.5 mg

Intervention Type DRUG

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.

Placebo

Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Interventions

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Rivaroxaban, 10 mg

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.

Intervention Type DRUG

Rivaroxaban, 7.5 mg

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.

Intervention Type DRUG

Placebo

All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.

Intervention Type DRUG

Other Intervention Names

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Xarelto BAY59-7939 Xarelto BAY59-7939

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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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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T'bilisi, , 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

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Countries

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United States Argentina Australia Austria Belarus Bosnia and Herzegovina Brazil Bulgaria Canada Colombia Croatia Czechia Denmark Estonia Georgia Germany Greece Hungary Israel Latvia Lithuania Mexico Netherlands North Macedonia Peru Poland Portugal Puerto Rico Romania Russia Serbia Slovakia South Africa Spain Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26842902 (View on PubMed)

Raskob 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.

Reference Type DERIVED
PMID: 36205248 (View on PubMed)

Spyropoulos 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.

Reference Type DERIVED
PMID: 35389229 (View on PubMed)

Raskob 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.

Reference Type DERIVED
PMID: 34755519 (View on PubMed)

Jamil 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.

Reference Type DERIVED
PMID: 32657973 (View on PubMed)

Spyropoulos 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.

Reference Type DERIVED
PMID: 32586587 (View on PubMed)

Weitz 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.

Reference Type DERIVED
PMID: 31975354 (View on PubMed)

Spyropoulos 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.

Reference Type DERIVED
PMID: 30145946 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-000305-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RIVAROXDVT3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR103834

Identifier Type: -

Identifier Source: org_study_id

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