Trial Condition(s):

Atrial Fibrillation

Explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion (X-VERT)

Bayer Identifier:

15693

ClinicalTrials.gov Identifier:

NCT01674647

EudraCT Number:

2011-002234-39

Study Completed

Trial Purpose

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

Inclusion Criteria
- Men or women aged >= 18 years
 - Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
 - Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
 - Women of childbearing potential and men must agree to use adequate contraception when sexually active
Exclusion Criteria
- Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
 - Transient ischemic attack within 3 days prior to randomization
 - Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
 - Acute Myocardial infarction (MI) within the last 14 days prior to randomization
 - Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation 
 - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
 - Concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used systemically
 - Concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
 - Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
 - Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Trial Summary

Enrollment Goal
1504
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Milano, Italy, 20097

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95126

Status
Completed
 
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Ancona, Italy, 60126

Status
Completed
 
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Como, Italy, 22020

Status
Completed
 
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Bari, Italy, 70021

Status
Completed
 
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Venezi, Italy, 30174

Status
Completed
 
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Torino, Italy, 10126

Status
Completed
 
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Roma, Italy, 00169

Status
Completed
 
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Kuils River, South Africa, 7580

Status
Completed
 
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Worcester, South Africa, 6850

Status
Completed
 
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Bloemfontein, South Africa, 9301

Status
Completed
 
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Cape Town, South Africa, 7450

Status
Completed
 
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SOWETO, South Africa, 2013

Status
Completed
 
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Somerset West, South Africa, 7130

Status
Completed
 
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Alberton, South Africa, 1449

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Completed
 
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Majadahonda, Spain, 28222

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Completed
 
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Barcelona, Spain, 08036

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Completed
 
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Granada, Spain, 18012

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Completed
 
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Pamplona, Spain, 31008

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Completed
 
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Sabadell, Spain, 08208

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Completed
 
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Heraklion, Greece, 711 10

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Completed
 
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Thessaloniki, Greece, 54642

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Completed
 
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Alexandroupolis, Greece, 68100

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Completed
 
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Attica / Athens, Greece, 11526

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Completed
 
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Viborg, Denmark, 8800

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Completed
 
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Herning, Denmark, 7400

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Completed
 
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Hellerup, Denmark, 2900

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Completed
 
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København NV, Denmark, 2400

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Completed
 
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HEERLEN, Netherlands, 6419 PC

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Completed
 
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MAASTRICHT, Netherlands, 6229 HX

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Completed
 
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LEEUWARDEN, Netherlands, 8934 AD

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Completed
 
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Welwyn Garden City, United Kingdom, AL7 4HQ

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Completed
 
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ARNHEM, Netherlands, 6815 AD

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HAARLEM, Netherlands, 2035 RC

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Frankfurt, Germany, 60596

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Completed
 
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Mönchengladbach, Germany, 41063

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Completed
 
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Montreal, Canada, H1T 1C8

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Completed
 
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Turku, Finland, 20521

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Completed
 
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Lappeenranta, Finland

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Completed
 
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Pori, Finland, 28500

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Completed
 
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Jyväskylä, Finland, 40620

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Oulu, Finland

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Berlin, Germany, 13353

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Edmonton, Canada, T5H 3V9

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LEUVEN, Belgium, 3000

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Singapore, Singapore, 168752

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Singapore, Singapore, 308433

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Completed
 
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Singapore, Singapore, 768828

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Completed
 
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Toronto, Canada, M5B 1W8

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Completed
 
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Hamilton, Canada, L8L 2X2

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Completed
 
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LILLE, France, 59000

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Completed
 
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ARRAS, France, 62000

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Paris cedex 13, France, 75013

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TOULOUSE cedex, France, 31059

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Completed
 
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VANDOEUVRE-LES-NANCY, France, 54511

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Completed
 
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Vila Nova de Gaia, Portugal, 4434-502

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Completed
 
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Lisboa, Portugal, 1169-024

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Completed
 
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Almada, Portugal, 2801-951

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Completed
 
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Carnaxide, Portugal, 2795-53

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Completed
 
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Faro, Portugal, 8000-386

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Completed
 
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Sao Martinho do Bispo, Portugal, 3041-801

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Completed
 
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Essen, Germany, 45147

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Completed
 
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Hamburg, Germany, 20246

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Completed
 
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Freiburg, Germany, 79106

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Completed
 
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Bad Oeynhausen, Germany, 32545

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Completed
 
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Bournemouth, United Kingdom, BH7 7DW

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Completed
 
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Portsmouth, United Kingdom, PO6 3LY

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Completed
 
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Chesterfield, United Kingdom, S44 5DX

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Completed
 
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Leicester, United Kingdom, LE3 9QP

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Completed
 
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Nottingham, United Kingdom, NG5 1PB

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Cliftonville, United Kingdom, NN1 5BD

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London, United Kingdom, SW17 0RE

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Rapid City, United States, 57701

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Lincoln, United States, 68506

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Completed
 
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Mobile, United States, 36608

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Completed
 
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Tallahassee, United States, 32308

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Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1070

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Completed
 
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HASSELT, Belgium, 3500

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Completed
 
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LIEGE, Belgium, 4000

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Completed
 
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MOL, Belgium, 2400

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Completed
 
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GILLY, Belgium, 6060

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Vaasa, Finland, 65130

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Completed
 
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Tampere, Finland, FIN-33520

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Completed
 
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Singapore, Singapore, 119228

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Completed
 
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Canton, United States, 44710

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Completed
 
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Buffalo, United States, 14215

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Completed
 
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Miramar, United States, 33025

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Completed
 
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Sacramento, United States, 95819

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Completed
 
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Doylestown, United States, 18901

Status
Completed
 
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Wausau, United States, 54401

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Completed
 
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National City, United States, 91950

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Completed
 
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El Cajon, United States, 92020

Status
Completed
 
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Madrid, Spain, 28007

Status
Completed
 
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Montreal, Canada, H2W 1T8

Status
Completed
 
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Rockford, United States, 61107

Status
Completed
 
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New York, United States, 10032

Status
Completed
 
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Dresden, Germany, 01067

Status
Completed
 
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Scottsdale, United States, 85258

Status
Completed
 
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Nürnberg, Germany, 90471

Status
Completed
 
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Leipzig, Germany, 04289

Status
Completed
 
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Toledo, United States, 43623

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Completed
 
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Albuquerque, United States, 87102

Status
Completed
 
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Stamford, United States, 06905

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Completed
 
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Butler, United States, 16001

Status
Completed
 
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Helsinki, Finland, FIN-00260

Status
Completed
 
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Victoria, Canada, V8R 4R2

Status
Completed
 
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Investigative Site

Layton, United States, 84041

Status
Completed
 
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Cleveland, United States, 44195

Status
Completed
 
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Tyler, United States, 75701

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Completed
 
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Clearwater, United States, 33756

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Completed
 
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Deltona, United States, 32725

Status
Completed
 
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Ft. Lauderdale, United States, 33316

Status
Completed
 
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Investigative Site

Bridgewater, United States, 08807

Status
Completed
 
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Daytona Beach, United States, 32117

Status
Completed
 
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Investigative Site

Fort Sam Houston, United States, 78234-6200

Status
Completed
 
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Wilmington, United States, 19803

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19141

Status
Completed
 
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Hershey, United States, 17033

Status
Completed
 
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Investigative Site

Annapolis, United States, 21401

Status
Completed
 
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Investigative Site

Beijing, China, 100029

Status
Completed
 
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Investigative Site

Xi'an, China, 710061

Status
Completed
 
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Orlando, United States, 32806

Status
Completed
 
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Shenyang, China, 110016

Status
Completed
 
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Wuhan, China

Status
Completed
 
Locations

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Urumqi, China, 830054

Status
Completed
 
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Guangzhou, China, 510080

Status
Completed
 
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Nanchang, China, 330006

Status
Completed
 
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Investigative Site

Changchun, China, 130021

Status
Completed
 
Locations

Investigative Site

Torrance, United States, 90502

Status
Completed
 
Locations

Investigative Site

Troy, United States, 12180

Status
Completed
 
Locations

Investigative Site

Manalapan, United States, 07716

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Completed
 
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Investigative Site

Austin, United States, 78745

Status
Completed
 
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Investigative Site

New Haven, United States, 06520

Status
Completed
 
Locations

Investigative Site

Melbourne, United States, 32901

Status
Completed
 
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Investigative Site

St. Augustine, United States, 32086

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32216

Status
Completed
 
Locations

Investigative Site

Joliet, United States, 60435

Status
Completed
 
Locations

Investigative Site

TOURS, France, 37044

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75012

Status
Completed
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Completed
 
Locations

Investigative Site

St. John's, Canada, A1B 3V6

Status
Completed
 

Trial Design