Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
MAGELLAN
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
2 other identifiers
interventional
8,101
50 countries
650
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Typical duration for phase_3
650 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
June 27, 2012
CompletedSeptember 15, 2016
August 1, 2016
2.7 years
December 11, 2007
February 16, 2012
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 35 + 6 days
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Up to Day 10 + 5 days
Secondary Outcomes (12)
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
Up to Day 35 + 6 days
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
Up to Day 10 + 5 days
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
Up to Day 10 + 5 days
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
Up to Day 35 + 6 days
- +7 more secondary outcomes
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALParticipants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Enoxaparin
ACTIVE COMPARATORParticipants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
Interventions
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (676)
Unknown Facility
Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35235, United States
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Dothan, Alabama, 36301, United States
Office of Dr. John Simmons, MD
Geneva, Alabama, 36340, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36111, United States
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Tuscaloosa, Alabama, 35401, United States
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Tuscaloosa, Alabama, 35406, United States
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Little Rock, Arkansas, 72205, United States
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Chula Vista, California, 91911, United States
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Duarte, California, 91010, United States
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Encinitas, California, 92024, United States
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Fountain Valley, California, 92708, United States
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Fullerton, California, 92835, United States
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Glendale, California, 91206, United States
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Oceanside, California, 92056, United States
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Pasadena, California, 91105, United States
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Redlands, California, 92373, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92120, United States
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Santa Barbara, California, 93102, United States
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Torrance, California, 90502-2004, United States
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Denver, Colorado, 80204, United States
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Pueblo, Colorado, 81003, United States
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Wheat Ridge, Colorado, 80033-6017, United States
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Farmington, Connecticut, 06030, United States
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Newark, Delaware, 19718, United States
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Washington D.C., District of Columbia, 20037, United States
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Aventura, Florida, 33180, United States
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Boyton Beach, Florida, 33472, United States
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Clearwater, Florida, 33756, United States
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Delray Beach, Florida, 33445, United States
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Fort Lauderdale, Florida, 33334, United States
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Hollywood, Florida, 33021, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33173-3259, United States
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Miami Springs, Florida, 33166, United States
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Pembroke Pines, Florida, 33024, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34232, United States
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Vero Beach, Florida, 32960, United States
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Atlanta, Georgia, 30342, United States
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Decatur, Georgia, 30030, United States
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Fort Gordon, Georgia, 30905, United States
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Savannah, Georgia, 31405, United States
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Idaho Falls, Idaho, 83404, United States
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Chicago, Illinois, 60611, United States
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Springfield, Illinois, 62702, United States
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Anderson, Indiana, 46011, United States
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Noblesville, Indiana, 46060, United States
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Des Moines, Iowa, 50314-2611, United States
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Olathe, Kansas, 66061, United States
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Lafayette, Louisiana, 70503, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71130-4228, United States
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Biddeford, Maine, 04005, United States
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Rockport, Maine, 04856, United States
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Baltimore, Maryland, 21215, United States
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Baltimore, Maryland, 21237, United States
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Framingham, Massachusetts, 01702, United States
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Ann Arbor, Michigan, 48106, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49525, United States
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Lansing, Michigan, 48910, United States
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Petoskey, Michigan, 49770-2297, United States
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Pontiac, Michigan, 48341, United States
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Saint Clair Shores, Michigan, 48081, United States
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Minneapolis, Minnesota, 55417, United States
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Kansas City, Missouri, 64128, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63141, United States
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Anaconda, Montana, 59711-2718, United States
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Great Falls, Montana, 59405, United States
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Omaha, Nebraska, 68131, United States
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Hackensack, New Jersey, 07601-1991, United States
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New Brunswick, New Jersey, 08901, United States
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Somerville, New Jersey, 08876-2598, United States
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Summit, New Jersey, 07901, United States
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Teaneck, New Jersey, 07666, United States
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Brooklyn, New York, 11215, United States
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Buffalo, New York, 14215-3021, United States
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Jamaica, New York, 11418, United States
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New Hyde Park, New York, 11040-1496, United States
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New York, New York, 10011, United States
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New York, New York, 10065, United States
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Stony Brook, New York, 11794, United States
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Valhalla, New York, 10595, United States
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Durham, North Carolina, 27710, United States
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Elizabeth City, North Carolina, 27909, United States
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Greensboro, North Carolina, 27403, United States
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Fargo, North Dakota, 58122, United States
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Canton, Ohio, 44718, United States
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Columbus, Ohio, 43215, United States
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Maumee, Ohio, 43537-1899, United States
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Toledo, Ohio, 43606, United States
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Bethlehem, Pennsylvania, 18015, United States
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Camp Hill, Pennsylvania, 17011, United States
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Danville, Pennsylvania, 17822, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19124, United States
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Scranton, Pennsylvania, 18510, United States
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Wilkes-Barre, Pennsylvania, 18711-3752, United States
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Charleston, South Carolina, 29425, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37232-2650, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75216-7167, United States
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Edinburg, Texas, 78539, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030-4009, United States
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Houston, Texas, 77030, United States
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McAllen, Texas, 78503, United States
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San Antonio, Texas, 78218, United States
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Ogden, Utah, 84403, United States
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Richmond, Virginia, 23249, United States
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Richmond, Virginia, 23298, United States
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Everett, Washington, 98201, United States
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Tacoma, Washington, 98405, United States
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Clarksburg, West Virginia, 26301, United States
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Avellaneda, Buenos Aires, B1870CID, Argentina
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San Miguel, Buenos Aires, 1663, Argentina
Hospital de Agudos "Dr. Carlos Bocalandro"
Tres de Febrero, Buenos Aires, 1657, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, 1221, Argentina
Hospital Británico
Buenos Aires, Ciudad Auton. de Buenos Aires, 1280, Argentina
Sanatorio Mitre
Buenos Aires, Ciudad Auton. de Buenos Aires, C1039AAO, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1431FWO, Argentina
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Vicente López, 1638, Argentina
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Garran, Australian Capital Territory, 2605, Australia
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Kogarah, New South Wales, 2217, Australia
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Lismore, New South Wales, 2480, Australia
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Sydney, New South Wales, 2229, Australia
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Auchenflower, Queensland, 4066, Australia
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Brisbane, Queensland, 4066, Australia
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Brisbane, Queensland, 4101, Australia
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Redcliffe, Queensland, 4020, Australia
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Southport, Queensland, 4215, Australia
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Woollongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5042, Australia
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Launceston, Tasmania, 7250, Australia
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Box Hill, Victoria, 3128, Australia
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Clayton, Victoria, 3168, Australia
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Melbourne, Victoria, 3135, Australia
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Melbourne, Victoria, 3144, Australia
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Perth, Western Australia, 6000, Australia
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Kittsee, Burgenland, 2421, Austria
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Oberpullendorf, Burgenland, 7350, Austria
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Wolfsberg, Carinthia, 9400, Austria
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Gratwein, Styria, 8113, Austria
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Graz, Styria, 8036, Austria
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Hartberg, Styria, 8230, Austria
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Leoben, Styria, 8700, Austria
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Zams, Tyrol, 6511, Austria
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Linz, Upper Austria, 4020, Austria
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Vienna, Vienna, 1030, Austria
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Vienna, Vienna, 1100, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Mürzzuschlag, 8680, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1100, Austria
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Vienna, 1140, Austria
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Aalst, 9300, Belgium
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Bruges, 8000, Belgium
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Bruxelles - Brussel, 1000, Belgium
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Dendermonde, 9200, Belgium
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Hasselt, 3500, Belgium
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Huy, 4500, Belgium
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Ieper, 8900, Belgium
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Leuven, 3000, Belgium
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Malmedy, 4960, Belgium
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Mol, 2400, Belgium
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Montigny S/sambre, 6061, Belgium
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Mortsel, 2640, Belgium
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Roeselare, 8800, Belgium
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Sint-Niklaas, 9100, Belgium
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Tubize, 1480, Belgium
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Turnhout, 2300, Belgium
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Curitiba, Paraná, 80050-350, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Campinas, São Paulo, 130839 970, Brazil
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Santo André, São Paulo, 09190-610, Brazil
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São Paulo, São Paulo, 01323-001, Brazil
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São Paulo, São Paulo, 04039 002, Brazil
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São Paulo, São Paulo, 05403-900, Brazil
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São Paulo, São Paulo, 05443000, Brazil
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Pleven, 5800, Bulgaria
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Rousse, 7002, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9010, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Calgary, Alberta, T2N 2T9, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Edmonton, Alberta, T6L 5X8, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Cobourg, Ontario, K9A 5W6, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Scarborough Village, Ontario, M1P 2V5, Canada
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Toronto, Ontario, M5T 2S8, Canada
Hotel Dieu-Grace Hospital
Windsor, Ontario, N9A 1E1, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Québec, Quebec, G1V 4G5, Canada
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Ste-Foy, Quebec, G1V 4G5, Canada
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Santiago, 760 0448, Chile
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Santiago, Chile
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Viña del Mar, Chile
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Guangzhou, Guangdong, 510120, China
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Guangzhou, Guangdong, 510405, China
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Guangzhou, Guangdong, China
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Changsha, Hunan, 410013, China
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Nanjing, Jiangsu, 210008, China
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Nanjing, Jiangsu, China
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Changchun, Jilin, China
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Dalian, Liaoning, 116027, China
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Shenyang, Liaoning, 110001, China
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Shenyang, Liaoning, 110004, China
Unknown Facility
Shenyang, Liaoning, 110015, China
The 1st Affiliated Hosp of the 4th Military Med Uni
Xi'an, Shaanxi, 710032, China
1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.
Xi'an, Shaanxi, 710061, China
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Chengdu, Sichuan, 610041, China
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Beijing, 100005, China
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Beijing, 100020, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100037, China
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Beijing, 100044, China
Beijing Friendship Hosp.
Beijing, 100050, China
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Beijing, 100050, China
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Beijing, 100053, China
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Beijing, 100088, China
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Beijing, 100853, China
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Chongqing, 400038, China
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Chongqing, 400042, China
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Shanghai, 200003, China
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Shanghai, 200025, China
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Shanghai, 200127, China
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Shanghai, 200233, 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, 310 00, Croatia
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Rijeka, 51000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Zagreb, 1000, Croatia
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Brno, 656 91, Czechia
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Kutná Hora, 284 30, Czechia
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Nové Město na Moravě, 592 31, Czechia
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Olomouc, 775 20, Czechia
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Pilsen, 305 99, Czechia
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Prague, 128 08, Czechia
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Prague, 128 21, Czechia
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Prague, 12808, Czechia
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Říčany, 251 49, Czechia
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Znojmo, 669 02, Czechia
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Esbjerg, 6700, Denmark
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Frederiksberg C, 2000, Denmark
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Kolding, 6000, Denmark
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København NV, 2400, Denmark
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København S, 2300, Denmark
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Roskilde, 4000, Denmark
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Tallinn, 10138, Estonia
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Tallinn, 13419, Estonia
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Tallinn, EE-10617, Estonia
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Tartu, EE-51014, Estonia
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Hämeenlinna, 13530, Finland
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Helsinki, 00290, Finland
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Jyväskylä, 40620, Finland
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Lahti, 15850, Finland
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Lappeenranta, 53130, Finland
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Raisio, 21200, Finland
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Turku, 20520, Finland
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Turku, 20700, Finland
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Arras, 62000, France
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Besançon, 25000, France
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Brest, 29609, France
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Castelnau-le-Lez, 34170, France
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Clermont-Ferrand, 63000, France
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Colombes, 92701, France
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Dijon, 21000, France
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Lille, 59037, France
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Lille, 59307, France
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Limoges, 87042, France
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Lomme, 59160, France
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Lyon, 69003, France
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Montpellier, 34295, France
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Nice, 06280, France
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Nîmes, 30029, France
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Paris, 75004, France
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Paris, 75010, France
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Paris, 75475, France
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Paris, 75877, France
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Pierre-Bénite, 69495, France
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Reims, 51092, France
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Roubaix, 59100, France
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Saint-Etienne, 42000, France
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Saint-Herblain, 44805, France
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Strasbourg, 67091, France
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Toulouse, 31403, France
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Tourcoing, 59208, France
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Vandœuvre-lès-Nancy, 54511, France
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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany
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Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
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Heidelberg, Baden-Wurttemberg, 69120, Germany
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Karlsbad, Baden-Wurttemberg, 76307, Germany
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Weiden, Bavaria, 92637, Germany
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Beeskow, Brandenburg, 15848, Germany
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Frankfurt (Oder), Brandenburg, 15236, Germany
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Bremen, City state Bremen, 28177, Germany
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Cologne, North Rhine-Westphalia, 50935, Germany
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Cologne, North Rhine-Westphalia, 51067, Germany
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Cologne, North Rhine-Westphalia, 51109, Germany
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Dortmund, North Rhine-Westphalia, 44137, Germany
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Jülich, North Rhine-Westphalia, 52428, Germany
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Leverkusen, North Rhine-Westphalia, 51375, Germany
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Mönchengladbach, North Rhine-Westphalia, 41063, Germany
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Neuss, North Rhine-Westphalia, 41464, Germany
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Oberhausen, North Rhine-Westphalia, 46045, Germany
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Paderborn, North Rhine-Westphalia, 33098, Germany
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Soest, North Rhine-Westphalia, 59494, Germany
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Stolberg, North Rhine-Westphalia, 52222, Germany
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Troisdorf, North Rhine-Westphalia, 53844, Germany
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Viersen, North Rhine-Westphalia, 41749, Germany
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Wuppertal, North Rhine-Westphalia, 42109, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Neuwied, Rhineland-Palatinate, 56564, Germany
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Dresden, Saxony, 01067, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04289, Germany
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Pirna, Saxony, 01796, Germany
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Halle, Saxony-Anhalt, 06112, Germany
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Berlin, State of Berlin, 10787, Germany
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Elefsina, Attica, 19018, Greece
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Kifisia / Athens, Attica, 14561, Greece
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Abelokipi - Athens, 115 26, Greece
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Athens, 106 76, Greece
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Athens, 115 26, Greece
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Athens, 156 69, Greece
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Nea Ionia, 14233, Greece
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Piraeus, 18536, Greece
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Rio / Patras, 265 04, Greece
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Shatin, N.t., Hong Kong
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Shatin, Hong Kong
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Baja, 6500, Hungary
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Balassagyarmat, 2660, Hungary
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Budapest, 1076, Hungary
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Budapest, 1134, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4012, Hungary
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Győr, 9024, Hungary
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Hódmezővásárhely, 6800, Hungary
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Kecskemét, 6000, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Zalaegerszeg-Pozva, H-8900, Hungary
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Ahmedabad, Gujar?t, 380 054, India
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Bangalore, Karn?taka, 560052, India
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Bangalore, Karn?taka, 560099, India
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Calicut, Kerala, 673 004, India
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Thiruvananthapuram, Kerala, 695002, India
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Pune, Maharashtra, 411001, India
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Pune, Maharashtra, 411011, India
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Ludhiana, Punjab, 141001, India
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Chennai, Tamil N?du, 600081, India
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Coimbatore, Tamil N?du, 641 004, India
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Kolkata, West Bengal, 700 099, India
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Hyderabad, 500034, India
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Hyderabad, 500082, India
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Hyderabad, 600 038, India
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Mumbai, 400022, India
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Noida, India
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Jakarta, 10430, Indonesia
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Jakarta, 11420, Indonesia
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Surabaya, 60286, Indonesia
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Afula, 1834111, Israel
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Ashkelon, 7830604, Israel
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Haifa, 31048, Israel
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Haifa, 3109601, Israel
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Holon, 58100, Israel
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Kfar Saba, 4428164, Israel
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Rehovot, 7610001, Israel
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Safed, 1311001, Israel
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Tel Aviv, 64239, Israel
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Acquaviva delle Fonti, Bari, 70021, Italy
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Napoli, Campania, 80123, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Parma, Emilia-Romagna, 43100, Italy
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Piacenza, Emilia-Romagna, 29121, Italy
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Reggio Emilia, Emilia-Romagna, 42123, Italy
Unknown Facility
Rome, Lazio, 00161, Italy
Unknown Facility
Rome, Lazio, 00168, Italy
Unknown Facility
Genoa, Liguria, 16128, Italy
Unknown Facility
Milan, Lombardy, 20089, Italy
Unknown Facility
Milan, Lombardy, 20133, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Varese, Lombardy, 21100, Italy
Unknown Facility
Campobasso, Molise, 86100, Italy
Unknown Facility
Fidenza, Parma, 43036, Italy
Unknown Facility
Catania, Sicily, 95124, Italy
Unknown Facility
Palermo, Sicily, 90127, Italy
Unknown Facility
Terni, Trentino-Alto Adige, 05019, Italy
Unknown Facility
Perugia, Umbria, 06024, Italy
Unknown Facility
Perugia, Umbria, 06156, Italy
Unknown Facility
Domodossola, Verbano-Cusio-Ossola, 28845, Italy
Unknown Facility
Bergamo, 24128, Italy
Unknown Facility
Latina, 04100, Italy
Unknown Facility
Reggio Calabria, 89124, Italy
Unknown Facility
Vicenza, 36100, Italy
Unknown Facility
Ichinomiya, Aichi-ken, 491-8551, Japan
Unknown Facility
Kasugai, Aichi-ken, 487-0013, Japan
Unknown Facility
Ōbu, Aichi-ken, 474-8511, Japan
Unknown Facility
Matsuyama, Ehime, 790-0024, Japan
Unknown Facility
Tōon, Ehime, 791-0281, Japan
Unknown Facility
Fukui-shi, Fukui, 910-8561, Japan
Unknown Facility
Chikushino-shi, Fukuoka, 818-8516, Japan
Unknown Facility
Takasaki, Gunma, 370-0829, Japan
Unknown Facility
Kure, Hiroshima, 737-0023, Japan
Unknown Facility
Hakodate, Hokkaido, 040-8611, Japan
Unknown Facility
Sapporo, Hokkaido, 065-0033, Japan
Unknown Facility
Amagasaki, Hyōgo, 660-8511, Japan
National Hospital Organization Ibaraki Higashi Hospital
Ibaraki, Ibaraki, 319-1113, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, 920-8650, Japan
Unknown Facility
Hanamaki, Iwate, 025-0075, Japan
Unknown Facility
Ebina, Kanagawa, 243-0433, Japan
Unknown Facility
Kamakura, Kanagawa, 247-8533, Japan
Unknown Facility
Yokohama, Kanagawa, 236-0051, Japan
Unknown Facility
Nangoku, Kochi, 783-8509, Japan
Unknown Facility
Kumamoto, Kumamoto, 860-0008, Japan
Unknown Facility
Kyoto, Kyoto, 606-8507, Japan
Unknown Facility
Matsusaka, Mie-ken, 515-8544, Japan
Unknown Facility
Tsu, Mie-ken, 514-1101, Japan
Unknown Facility
Tsu, Mie-ken, 514-8507, Japan
Unknown Facility
Kashiwazaki, Niigata, 945-8585, Japan
Unknown Facility
Tomigusuku, Okinawa, 901-0243, Japan
Unknown Facility
Urasoe, Okinawa, 901-2132, Japan
Unknown Facility
Daitō, Osaka, 574-0074, Japan
Unknown Facility
Yao, Osaka, 581-0011, Japan
Unknown Facility
Kusatsu, Shiga, 525-8585, Japan
Unknown Facility
Hamamatsu, Shizuoka, 432-8580, Japan
Unknown Facility
Meguro-ku, Tokyo, 152-8902, Japan
Unknown Facility
Shinjuku-ku, Tokyo, 162-8655, Japan
Unknown Facility
Shimonoseki, Yamaguchi, 750-0061, Japan
Unknown Facility
Daugavpils, LV-5417, Latvia
Unknown Facility
Liepāja, 3402, Latvia
Unknown Facility
Riga, 1002, Latvia
Unknown Facility
Riga, 1005, Latvia
Unknown Facility
Riga, LV-1001, Latvia
Unknown Facility
Riga, LV-1038, Latvia
Unknown Facility
Valmiera, LV-4201, Latvia
Unknown Facility
Ventspils, LV-3601, Latvia
Unknown Facility
Kaunas, LT-3000, Lithuania
Unknown Facility
Kaunas, LT-3002, Lithuania
Unknown Facility
Kaunas, LT-3026, Lithuania
Unknown Facility
Klaipėda, LT-5800, Lithuania
Unknown Facility
Klaipėda, LT-92231, Lithuania
Unknown Facility
Šiauliai, 76231, Lithuania
Unknown Facility
Utena, LT-28142, Lithuania
Unknown Facility
Vilnius, 04130, Lithuania
Unknown Facility
Vilnius, 10207, Lithuania
Unknown Facility
Vilnius, LT-2001, Lithuania
Unknown Facility
Luxembourg, 1210, Luxembourg
Unknown Facility
Luxembourg-Kirchberg, 2540, Luxembourg
Unknown Facility
Niedercorn, 4602, Luxembourg
Unknown Facility
Kuala Lumpur, 59100, Malaysia
Unknown Facility
Negeri Sembilan,, 70300, Malaysia
Unknown Facility
Sarawak, 93400, Malaysia
Unknown Facility
Aguascalientes, Aguascalientes, 20234, Mexico
Unknown Facility
Tuxtla Gutiérrez, Chiapas, 29000, Mexico
Unknown Facility
Chihuahua City, Chihuahua, 31350, Mexico
Unknown Facility
Torreón, Coahuila, 27250, Mexico
Unknown Facility
Guadalajara, Jalisco, 44280, Mexico
Unknown Facility
Mexico City, Mexico City, 11340, Mexico
Unknown Facility
Mexico City, Mexico City, 15900, Mexico
Unknown Facility
Mexico D. F., Mexico City, 06760, Mexico
Unknown Facility
México, D.F, Mexico City, 07460, Mexico
Unknown Facility
México, D.F., Mexico City, 06729, Mexico
Unknown Facility
México, D.F., Mexico City, 07760, Mexico
Unknown Facility
Morelia, Michoacán, 58270, Mexico
Unknown Facility
Monterrey, Nuevo León, 66480, Mexico
Unknown Facility
Puebla City, Puebla, 72410, Mexico
Unknown Facility
Hermosillo, Sonora, 83000, Mexico
Unknown Facility
Metepec, State of Mexico, 52140, Mexico
Unknown Facility
Mérida, Yucatán, 97001, Mexico
Unknown Facility
Zacatecas City, Zacatecas, 98000, Mexico
Unknown Facility
Amersfoort, 3816 CP, Netherlands
Unknown Facility
Amsterdam, 1061 AE, Netherlands
Unknown Facility
Enschede, 7511 JX, Netherlands
Unknown Facility
Heerlen, 6401 CX, Netherlands
Unknown Facility
Maastricht, 6229 HX, Netherlands
Unknown Facility
Nieuwegein, 3435 CM, Netherlands
Unknown Facility
Rotterdam, 3083 AN, Netherlands
Unknown Facility
Sittard, 6131 BK, Netherlands
Unknown Facility
Utrecht, 3582 KE, Netherlands
Unknown Facility
Auckland, 0622, New Zealand
Unknown Facility
Auckland, 1023, New Zealand
Unknown Facility
Auckland, 2024, New Zealand
Unknown Facility
Christchurch, 8011, New Zealand
Unknown Facility
Fredrikstad, 1603, Norway
Unknown Facility
Gjøvik, 2819, Norway
Unknown Facility
Hamar, 2326, Norway
Unknown Facility
Oslo, 0319, Norway
Unknown Facility
Oslo, 0407, Norway
Unknown Facility
Karachi, 74800, Pakistan
Unknown Facility
Karachi, 75500, Pakistan
Unknown Facility
Lahore, Pakistan
Unknown Facility
Callao, CALLAO 2, Peru
Unknown Facility
Lima, 01, Peru
Unknown Facility
Lima, 31, Peru
Unknown Facility
Lima, LIMA 11, Peru
Unknown Facility
Lima, LIMA 1, Peru
Unknown Facility
Lima Cercado, LIMA 1, Peru
Unknown Facility
Bialystok, 15-276, Poland
Unknown Facility
Bydgoszcz, 85-681, Poland
Unknown Facility
Krakow, 31-066, Poland
Unknown Facility
Krakow, 31-121, Poland
Unknown Facility
Lublin, 20-178, Poland
Unknown Facility
Olsztyn, 10-228, Poland
Unknown Facility
Piotrkow Trybunalski, 97-300, Poland
Unknown Facility
Siedlce, 08-110, Poland
Unknown Facility
Starogard Gdański, 83-200, Poland
Unknown Facility
Szczecin, 70-965, Poland
Unknown Facility
Tarnów, 33-100, Poland
Unknown Facility
Warsaw, 03-401, Poland
Unknown Facility
Warsaw, 04-141, Poland
Unknown Facility
Warsaw, 04-749, Poland
Unknown Facility
Włocławek, 87-800, Poland
Unknown Facility
S. Martinho Do Bispo, Coimbra District, 3041-856, Portugal
Unknown Facility
Lisbon, Lisbon District, 1150-199, Portugal
Unknown Facility
Lisbon, Lisbon District, 1649-035, Portugal
Unknown Facility
Porto, Porto District, 4099-001, Portugal
Unknown Facility
Santarém, Santarém District, 2005, Portugal
Unknown Facility
Amadora, 2720-276, Portugal
Unknown Facility
Cascais, 2750-349, Portugal
Unknown Facility
Coimbra, 3000-075, Portugal
Unknown Facility
Lisbon, 1349-019, Portugal
Unknown Facility
Lisbon, 1849- 017, Portugal
Unknown Facility
Matosinhos Municipality, 4454-509, Portugal
Unknown Facility
Porto, 4200-319, Portugal
Unknown Facility
Viana do Castelo, 4901-585, Portugal
Unknown Facility
Bucharest, 014461, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Bucharest, 041915, Romania
Unknown Facility
Constanța, 900591, Romania
Unknown Facility
Suceava, 720237, Romania
Unknown Facility
Moscow, 103030, Russia
Unknown Facility
Moscow, 115093, Russia
Unknown Facility
Moscow, 115516, Russia
Unknown Facility
Moscow, 117292, Russia
Unknown Facility
Moscow, 119048, Russia
Unknown Facility
Moscow, 119435, Russia
Unknown Facility
Moscow, 125101, Russia
Unknown Facility
Moscow, 125367, Russia
Unknown Facility
Nizhny Novgorod, 603001, Russia
Unknown Facility
Nizhny Novgorod, 603035, Russia
Unknown Facility
Yaroslavl, 150003, Russia
Unknown Facility
Yaroslavl, 150030, Russia
Unknown Facility
Singapore, 119074, Singapore
Unknown Facility
Singapore, 168752, Singapore
Unknown Facility
Singapore, 169608, Singapore
Unknown Facility
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Unknown Facility
Bratislava, 813 69, Slovakia
Unknown Facility
Bratislava, 826 06, Slovakia
Unknown Facility
Lučenec, 984 39, Slovakia
Unknown Facility
Martin, 036 59, Slovakia
Unknown Facility
Žilina, 012 07, Slovakia
Unknown Facility
Golnik, 4204, Slovenia
Unknown Facility
Ljubljana, 1000, Slovenia
Unknown Facility
Novo Mesto, 8000, Slovenia
Unknown Facility
Bloemfontein, Freestate, 9301, South Africa
Unknown Facility
Johannesburg, Gauteng, 2057, South Africa
Unknown Facility
Johannesburg, Gauteng, 2132, South Africa
Unknown Facility
Johannesburg, Gauteng, 2196, South Africa
Unknown Facility
Kempton Park, Gauteng, 1610, South Africa
Unknown Facility
Pretoria, Gauteng, 0084, South Africa
Unknown Facility
Pretoria, Gauteng, 0157, South Africa
Unknown Facility
Pretoria, Gauteng, 0181, South Africa
Unknown Facility
Roodepoort, Gauteng, 1724, South Africa
Unknown Facility
Sandton, Gauteng, South Africa, 2196, South Africa
Unknown Facility
Goodwood, Western Cape, 7460, South Africa
Unknown Facility
Somerset West, Western Cape, 7130, South Africa
Unknown Facility
Stellenbosch, Western Cape, 7505, South Africa
Unknown Facility
Worcester, Western Cape, 6850, South Africa
Unknown Facility
Gyeongi-do, Korea, 463-707, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 110-744, South Korea
Seoul Metropolitan Boramae Hospital
Seoul, Seoul Teugbyeolsi, 156-707, South Korea
Unknown Facility
Gyeonggi-do, 463-712, South Korea
Unknown Facility
Jeollanam-do, 519-763, South Korea
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Seoul, 138736, South Korea
Unknown Facility
Badalona, Barcelona, 08916, Spain
Unknown Facility
Barcelona, Barcelona, 08023, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Sabadell, Barcelona, 08208, Spain
Unknown Facility
Cuenca, Cuenca, 16002, Spain
Unknown Facility
Cabra, Córdoba, 14940, Spain
Unknown Facility
Córdoba, Córdoba, 14004, Spain
Unknown Facility
Girona, Girona, 17007, Spain
Unknown Facility
Olot, Girona, 17800, Spain
Unknown Facility
Cartagena, Murcia, 30202, Spain
Unknown Facility
Vélez, Málaga, 29700, Spain
Unknown Facility
Vigo, Pontevedra, 36214, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
Unknown Facility
Borås, 501 82, Sweden
Unknown Facility
Hässleholm, 281 25, Sweden
Unknown Facility
Karlshamn, 374 80, Sweden
Unknown Facility
Kristianstad, 29185, Sweden
Unknown Facility
Lund, 221 85, Sweden
Unknown Facility
Malmo, 205 02, Sweden
Unknown Facility
Skövde, 541 85, Sweden
Unknown Facility
Stockholm, 171 76, Sweden
Unknown Facility
Stockholm, 182 88, Sweden
Unknown Facility
Sundsvall, 851 86, Sweden
Unknown Facility
Umeå, 90185, Sweden
Unknown Facility
Visby, 62184, Sweden
Unknown Facility
Bruderholz, Basel-Landschaft, 4101, Switzerland
Unknown Facility
Basel, Canton of Basel-City, 4031, Switzerland
Unknown Facility
Liestal, Canton of Basel-City, 4410, Switzerland
Unknown Facility
Bern, Canton of Bern, 3010, Switzerland
Unknown Facility
Langenthal, Canton of Bern, 4901, Switzerland
Unknown Facility
Geneva, Canton of Geneva, 1211, Switzerland
Unknown Facility
Zurich, Canton of Zurich, 8091, Switzerland
Unknown Facility
Baden, 5404, Switzerland
Unknown Facility
Lucerne, 6000, Switzerland
Unknown Facility
Kaohsiung City, 833, Taiwan
Unknown Facility
Tainan, 710, Taiwan
Unknown Facility
Taipei, 10016, Taiwan
Unknown Facility
Taipei, 114, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Bangkok, Thailand, 10700, Thailand
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Chiang Mai, 50200, Thailand
Unknown Facility
Istanbul, 34098, Turkey (Türkiye)
Unknown Facility
Istanbul, 34304, Turkey (Türkiye)
Unknown Facility
Izmir, 35100, Turkey (Türkiye)
Unknown Facility
Izmir, 35340, Turkey (Türkiye)
Unknown Facility
Donetsk, 83003, Ukraine
Unknown Facility
Donetsk, 83045, Ukraine
Unknown Facility
Ivano-Frankivsk, 76000, Ukraine
Unknown Facility
Kharkiv, 61037, Ukraine
Unknown Facility
Kharkiv, 61070, Ukraine
Unknown Facility
Kharkiv, 61178, Ukraine
Unknown Facility
Kiev, 02 091, Ukraine
Unknown Facility
Kiev, 03680, Ukraine
Unknown Facility
Kiev, 04112, Ukraine
Unknown Facility
Kyiv, 01105, Ukraine
Unknown Facility
Lviv, 790 34, Ukraine
Unknown Facility
Odesa, 65009, Ukraine
Unknown Facility
Odesa, 65025, Ukraine
Unknown Facility
Simferopol, 95 026, Ukraine
Unknown Facility
Simferopol, 95023, Ukraine
Unknown Facility
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Unknown Facility
Dumfries, Dumfries and Galloway, DG1 4EP, United Kingdom
Unknown Facility
London, London, N18 1QX, United Kingdom
Unknown Facility
London, London, SE5 9RS, United Kingdom
Unknown Facility
Liverpool, Merseyside, L9 7JU, United Kingdom
Unknown Facility
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Unknown Facility
Glasgow, Stratchclyde, G11 6NT, United Kingdom
Unknown Facility
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Unknown Facility
London, W1T 4EU, United Kingdom
Unknown Facility
Nottingham, NG7 2UH, United Kingdom
Related Publications (12)
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.
PMID: 21359646RESULTCohen 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.
PMID: 23388003RESULTSharma 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.
PMID: 22863355RESULTMebazaa 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.
PMID: 24970782RESULTCohen 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.
PMID: 24460645RESULTSpyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.
PMID: 35389229DERIVEDRaskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.
PMID: 34755519DERIVEDRaskob 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.
PMID: 33586478DERIVEDJamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.
PMID: 32657973DERIVEDWeitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.
PMID: 31975354DERIVEDChi 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.
PMID: 28762617DERIVEDMarszalek 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.
PMID: 28617144DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A heterogeneous population (with different acute medical illnesses and severity of illness) was included in the trial. VTE risk in acute medical illnesses is moderate \[with no thromboprophylaxis\] .
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 12, 2007
Study Start
December 1, 2007
Primary Completion
August 1, 2010
Study Completion
November 1, 2010
Last Updated
September 15, 2016
Results First Posted
June 27, 2012
Record last verified: 2016-08