Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

NCT ID: NCT00571649

Last Updated: 2016-09-15

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

8101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-11-30

Brief Summary

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This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Detailed Description

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The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

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

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rivaroxaban (Xarelto, BAY59-7939)

Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

Enoxaparin placebo

Intervention Type DRUG

Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Enoxaparin

Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Rivaroxaban placebo

Intervention Type DRUG

Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

Intervention Type DRUG

Enoxaparin

Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Intervention Type DRUG

Rivaroxaban placebo

Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Intervention Type DRUG

Enoxaparin placebo

Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

* Heart failure, New York Heart Association (NYHA) class III or IV
* Active cancer
* Acute ischemic stroke
* Acute infectious and inflammatory diseases, including acute rheumatic diseases
* Acute respiratory insufficiency
* Additional risk factor for VTE, including reduced mobility

Exclusion Criteria

* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Office of Dr. John Simmons, MD

Geneva, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Tuscaloosa, Alabama, United States

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Tuscaloosa, Alabama, United States

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Little Rock, Arkansas, United States

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Chula Vista, California, United States

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Duarte, California, United States

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Encinitas, California, United States

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Fountain Valley, California, United States

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Fullerton, California, United States

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Glendale, California, United States

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Oceanside, California, United States

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Pasadena, California, United States

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Redlands, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Pueblo, Colorado, United States

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Wheat Ridge, Colorado, United States

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Farmington, Connecticut, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Boyton Beach, Florida, United States

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Clearwater, Florida, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Hollywood, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Springs, Florida, United States

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Pembroke Pines, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Fort Gordon, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Anderson, Indiana, United States

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Noblesville, Indiana, United States

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Des Moines, Iowa, United States

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Olathe, Kansas, United States

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Lafayette, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Biddeford, Maine, United States

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Rockport, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Framingham, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Lansing, Michigan, United States

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Petoskey, Michigan, United States

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Pontiac, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Anaconda, Montana, United States

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Great Falls, Montana, United States

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Omaha, Nebraska, United States

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Hackensack, New Jersey, United States

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New Brunswick, New Jersey, United States

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Somerville, New Jersey, United States

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Summit, New Jersey, United States

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Teaneck, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Jamaica, 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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New York, New York, United States

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Stony Brook, 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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Elizabeth City, North Carolina, United States

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Greensboro, North Carolina, United States

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Fargo, North Dakota, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Maumee, Ohio, United States

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Toledo, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Tacoma, Washington, United States

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Clarksburg, West Virginia, United States

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Avellaneda, Buenos Aires, Argentina

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San Miguel, Buenos Aires, Argentina

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Hospital de Agudos "Dr. Carlos Bocalandro"

Tres de Febrero, Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Hospital Británico

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Sanatorio Mitre

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Vicente López, , Argentina

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Garran, Australian Capital Territory, Australia

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Kogarah, New South Wales, Australia

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Lismore, New South Wales, Australia

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Sydney, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Brisbane, Queensland, Australia

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Brisbane, Queensland, Australia

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Redcliffe, Queensland, Australia

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Southport, Queensland, Australia

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Woollongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Launceston, Tasmania, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Melbourne, Victoria, Australia

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Melbourne, Victoria, Australia

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Perth, Western Australia, Australia

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Kittsee, Burgenland, Austria

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Oberpullendorf, Burgenland, Austria

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Wolfsberg, Carinthia, Austria

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Gratwein, Styria, Austria

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Graz, Styria, Austria

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Hartberg, Styria, Austria

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Leoben, Styria, Austria

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Zams, Tyrol, Austria

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Linz, Upper Austria, Austria

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Vienna, Vienna, Austria

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Vienna, Vienna, Austria

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Innsbruck, , Austria

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Linz, , Austria

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Mürzzuschlag, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Bruges, , Belgium

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Bruxelles - Brussel, , Belgium

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Dendermonde, , Belgium

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Hasselt, , Belgium

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Huy, , Belgium

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Ieper, , Belgium

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Leuven, , Belgium

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Malmedy, , Belgium

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Mol, , Belgium

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Montigny S/sambre, , Belgium

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Mortsel, , Belgium

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Roeselare, , Belgium

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Sint-Niklaas, , Belgium

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Tubize, , Belgium

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Turnhout, , Belgium

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Cobourg, 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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Hotel Dieu-Grace Hospital

Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Santiago, , Chile

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Santiago, , Chile

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Viña del Mar, , Chile

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Nanjing, Jiangsu, China

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Changchun, Jilin, China

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Dalian, Liaoning, China

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Shenyang, Liaoning, China

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Shenyang, Liaoning, China

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Shenyang, Liaoning, China

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The 1st Affiliated Hosp of the 4th Military Med Uni

Xi'an, Shaanxi, China

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1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.

Xi'an, Shaanxi, China

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Chengdu, Sichuan, China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing Friendship Hosp.

Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Chongqing, , China

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Chongqing, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Medellín, Antioquia, Colombia

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Bogotá, Bogota D.C., Colombia

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Cali, Valle del Cauca Department, Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Medellín, , Colombia

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Osijek, , Croatia

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Rijeka, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Brno, , Czechia

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Kutná Hora, , Czechia

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Nové Město na Moravě, , Czechia

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Olomouc, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Říčany, , Czechia

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Znojmo, , Czechia

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Esbjerg, , Denmark

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Frederiksberg C, , Denmark

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Kolding, , Denmark

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København NV, , Denmark

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København S, , Denmark

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Roskilde, , Denmark

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Jyväskylä, , Finland

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Lahti, , Finland

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Lappeenranta, , Finland

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Raisio, , Finland

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Turku, , Finland

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Turku, , Finland

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Arras, , France

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Besançon, , France

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Brest, , France

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Castelnau-le-Lez, , France

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Clermont-Ferrand, , France

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Colombes, , France

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Dijon, , France

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Lille, , France

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Lille, , France

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Limoges, , France

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Lomme, , France

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Lyon, , France

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Montpellier, , France

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Nice, , France

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Nîmes, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Reims, , France

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Roubaix, , France

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Saint-Etienne, , France

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Saint-Herblain, , France

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Strasbourg, , France

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Toulouse, , France

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Tourcoing, , France

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Vandœuvre-lès-Nancy, , France

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Bad Mergentheim, Baden-Wurttemberg, Germany

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Esslingen am Neckar, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Karlsbad, Baden-Wurttemberg, Germany

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Weiden, Bavaria, Germany

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Beeskow, Brandenburg, Germany

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Frankfurt (Oder), Brandenburg, Germany

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Bremen, City state Bremen, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Jülich, North Rhine-Westphalia, Germany

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Leverkusen, North Rhine-Westphalia, Germany

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Mönchengladbach, North Rhine-Westphalia, Germany

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Neuss, North Rhine-Westphalia, Germany

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Oberhausen, North Rhine-Westphalia, Germany

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Paderborn, North Rhine-Westphalia, Germany

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Soest, North Rhine-Westphalia, Germany

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Stolberg, North Rhine-Westphalia, Germany

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Troisdorf, North Rhine-Westphalia, Germany

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Viersen, North Rhine-Westphalia, Germany

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Wuppertal, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Neuwied, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Pirna, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Elefsina, Attica, Greece

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Kifisia / Athens, Attica, Greece

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Abelokipi - Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Nea Ionia, , Greece

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Piraeus, , Greece

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Rio / Patras, , Greece

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Shatin, N.t., Hong Kong

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Shatin, , Hong Kong

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Baja, , Hungary

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Hódmezővásárhely, , Hungary

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Kecskemét, , Hungary

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Székesfehérvár, , Hungary

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Tatabánya, , Hungary

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Zalaegerszeg-Pozva, , Hungary

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Ahmedabad, Gujar?t, India

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Bangalore, Karn?taka, India

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Bangalore, Karn?taka, India

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Calicut, Kerala, India

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Thiruvananthapuram, Kerala, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Chennai, Tamil N?du, India

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Coimbatore, Tamil N?du, India

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Kolkata, West Bengal, India

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Hyderabad, , India

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Hyderabad, , India

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Hyderabad, , India

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Mumbai, , India

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Noida, , India

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Jakarta, , Indonesia

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Jakarta, , Indonesia

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Surabaya, , Indonesia

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Afula, , Israel

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Ashkelon, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Holon, , Israel

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Kfar Saba, , Israel

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Rehovot, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Acquaviva delle Fonti, Bari, Italy

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Napoli, Campania, Italy

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Modena, Emilia-Romagna, Italy

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Parma, Emilia-Romagna, Italy

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Piacenza, Emilia-Romagna, Italy

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Reggio Emilia, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Varese, Lombardy, Italy

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Campobasso, Molise, Italy

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Fidenza, Parma, Italy

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Catania, Sicily, Italy

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Palermo, Sicily, Italy

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Terni, Trentino-Alto Adige, Italy

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Perugia, Umbria, Italy

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Perugia, Umbria, Italy

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Domodossola, Verbano-Cusio-Ossola, Italy

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Bergamo, , Italy

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Latina, , Italy

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Reggio Calabria, , Italy

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Vicenza, , Italy

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Ichinomiya, Aichi-ken, Japan

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Kasugai, Aichi-ken, Japan

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Ōbu, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Tōon, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Chikushino-shi, Fukuoka, Japan

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Takasaki, Gunma, Japan

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Kure, Hiroshima, Japan

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Hakodate, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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National Hospital Organization Ibaraki Higashi Hospital

Ibaraki, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Hanamaki, Iwate, Japan

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Ebina, Kanagawa, Japan

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Kamakura, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Nangoku, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Matsusaka, Mie-ken, Japan

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Tsu, Mie-ken, Japan

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Tsu, Mie-ken, Japan

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Kashiwazaki, Niigata, Japan

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Tomigusuku, Okinawa, Japan

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Urasoe, Okinawa, Japan

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Daitō, Osaka, Japan

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Yao, Osaka, Japan

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Kusatsu, Shiga, Japan

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Hamamatsu, Shizuoka, Japan

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Meguro-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shimonoseki, Yamaguchi, Japan

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Daugavpils, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Valmiera, , Latvia

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Ventspils, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Klaipėda, , Lithuania

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Šiauliai, , Lithuania

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Utena, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Luxembourg, , Luxembourg

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Luxembourg-Kirchberg, , Luxembourg

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Niedercorn, , Luxembourg

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Kuala Lumpur, , Malaysia

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Negeri Sembilan,, , Malaysia

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Sarawak, , Malaysia

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Aguascalientes, Aguascalientes, Mexico

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Tuxtla Gutiérrez, Chiapas, Mexico

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Chihuahua City, Chihuahua, Mexico

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Torreón, Coahuila, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Mexico D. F., Mexico City, Mexico

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México, D.F, Mexico City, Mexico

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México, D.F., Mexico City, Mexico

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México, D.F., Mexico City, Mexico

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Morelia, Michoacán, Mexico

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Monterrey, Nuevo León, Mexico

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Puebla City, Puebla, Mexico

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Hermosillo, Sonora, Mexico

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Metepec, State of Mexico, Mexico

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Mérida, Yucatán, Mexico

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Zacatecas City, Zacatecas, Mexico

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Amersfoort, , Netherlands

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Amsterdam, , Netherlands

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Enschede, , Netherlands

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Heerlen, , Netherlands

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Maastricht, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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Sittard, , Netherlands

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Utrecht, , Netherlands

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Auckland, , New Zealand

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Auckland, , New Zealand

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Fredrikstad, , Norway

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Gjøvik, , Norway

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Hamar, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Karachi, , Pakistan

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Karachi, , Pakistan

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Lahore, , Pakistan

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Callao, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima Cercado, , Peru

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Piotrkow Trybunalski, , Poland

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Siedlce, , Poland

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Starogard Gdański, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Włocławek, , Poland

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S. Martinho Do Bispo, Coimbra District, Portugal

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Lisbon, Lisbon District, Portugal

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Lisbon, Lisbon District, Portugal

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Porto, Porto District, Portugal

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Santarém, Santarém District, Portugal

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Amadora, , Portugal

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Cascais, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Matosinhos Municipality, , Portugal

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Porto, , Portugal

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Viana do Castelo, , Portugal

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Constanța, , Romania

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Suceava, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Nizhny Novgorod, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Changi General Hospital

Singapore, , Singapore

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Lučenec, , Slovakia

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Martin, , Slovakia

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Žilina, , Slovakia

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Golnik, , Slovenia

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Ljubljana, , Slovenia

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Novo Mesto, , Slovenia

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Bloemfontein, Freestate, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Kempton Park, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Roodepoort, Gauteng, South Africa

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Sandton, Gauteng, South Africa, South Africa

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Goodwood, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Stellenbosch, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Gyeongi-do, Korea, South Korea

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Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

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Seoul Metropolitan Boramae Hospital

Seoul, Seoul Teugbyeolsi, South Korea

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Gyeonggi-do, , South Korea

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Jeollanam-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Cuenca, Cuenca, Spain

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Cabra, Córdoba, Spain

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Córdoba, Córdoba, Spain

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Girona, Girona, Spain

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Olot, Girona, Spain

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Cartagena, Murcia, Spain

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Vélez, Málaga, Spain

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Vigo, Pontevedra, Spain

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Zaragoza, Zaragoza, Spain

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Borås, , Sweden

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Hässleholm, , Sweden

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Karlshamn, , Sweden

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Kristianstad, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Umeå, , Sweden

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Visby, , Sweden

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Bruderholz, Basel-Landschaft, Switzerland

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Basel, Canton of Basel-City, Switzerland

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Liestal, Canton of Basel-City, Switzerland

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Bern, Canton of Bern, Switzerland

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Langenthal, Canton of Bern, Switzerland

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Geneva, Canton of Geneva, Switzerland

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Zurich, Canton of Zurich, Switzerland

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Baden, , Switzerland

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Lucerne, , Switzerland

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Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Bangkok, Thailand, Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Donetsk, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kiev, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Simferopol, , Ukraine

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Middlesbrough, Cleveland, United Kingdom

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Dumfries, Dumfries and Galloway, United Kingdom

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London, London, United Kingdom

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London, London, United Kingdom

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Liverpool, Merseyside, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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Glasgow, Stratchclyde, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Colombia Croatia Czechia Denmark Estonia Finland France Germany Greece Hong Kong Hungary India Indonesia Israel Italy Japan Latvia Lithuania Luxembourg Malaysia Mexico Netherlands New Zealand Norway Pakistan Peru Poland Portugal Romania Russia Singapore Slovakia Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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

Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis. 2011 May;31(4):407-16. doi: 10.1007/s11239-011-0549-x.

Reference Type RESULT
PMID: 21359646 (View on PubMed)

Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

Reference Type RESULT
PMID: 23388003 (View on PubMed)

Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

Reference Type RESULT
PMID: 22863355 (View on PubMed)

Mebazaa A, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

Reference Type RESULT
PMID: 24970782 (View on PubMed)

Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

Reference Type RESULT
PMID: 24460645 (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)

Raskob GE, Spyropoulos AC, Cohen AT, Weitz JI, Ageno W, De Sanctis Y, Lu W, Xu J, Albanese J, Sugarmann C, Weber T, Lipardi C, Spiro TE, Barnathan ES. Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients. J Am Heart Assoc. 2021 Feb;10(5):e019459. doi: 10.1161/JAHA.120.019459. Epub 2021 Feb 15.

Reference Type DERIVED
PMID: 33586478 (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)

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)

Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

Reference Type DERIVED
PMID: 28762617 (View on PubMed)

Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

Reference Type DERIVED
PMID: 28617144 (View on PubMed)

Related Links

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Other Identifiers

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2007-004614-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12839

Identifier Type: -

Identifier Source: org_study_id

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