Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (Beyond)

Bayer Identifier:

91656

ClinicalTrials.gov Identifier:

NCT00459667

EudraCT Number:

2006-005270-47

EU CT Number:

Not Available

Study Completed

Trial Purpose

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Inclusion Criteria
- Completion of the BEYOND study 306440 as scheduled
 - Relapsing multiple sclerosis
 - Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
 - Females of child-bearing potential:
 -- Agreement to practice adequate contraception methods and
 -- Negative pregnancy test and
 -- No lactation
 - Written informed consent
Exclusion Criteria
- Serious or acute heart diseases
 - History of severe depression or suicide attempt
 - Epilepsy not adequately controlled by treatment
 - Known allergy to IFNs, to human albumin or to mannitol
 - Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Trial Summary

Enrollment Goal
1420
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
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Investigative Site

Tualatin, United States, 97062

Status
Completed
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Investigative Site

Birmingham, United States, 35294-7340

Status
Completed
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Investigative Site

Reno, United States, 89509

Status
Completed
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Investigative Site

Duluth, United States, 55805

Status
Completed
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Investigative Site

Newark, United States, 07103

Status
Completed
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Investigative Site

Tucson, United States, 85741

Status
Completed
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Investigative Site

Stony Brook, United States, 11794

Status
Completed
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Investigative Site

Detroit, United States, 48202

Status
Completed
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Investigative Site

Albuquerque, United States, 87131-5281

Status
Completed
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Investigative Site

Fort Wayne, United States, 46805

Status
Completed
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Investigative Site

Des Moines, United States, 50314

Status
Completed
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Investigative Site

Sacramento, United States, 95817

Status
Completed
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Investigative Site

Chicago, United States, 60637

Status
Completed
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Investigative Site

Tampa, United States, 33609

Status
Completed
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Berkeley, United States, 94705

Status
Completed
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Investigative Site

Tampa, United States, 33606

Status
Completed
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San Francisco, United States, 94117

Status
Completed
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Rochester, United States, 14642

Status
Completed
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Investigative Site

Mineola, United States, 11501

Status
Completed
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Nashville, United States, 37205

Status
Completed
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Durham, United States, 27710

Status
Completed
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Investigative Site

Winston-Salem, United States, 27157

Status
Completed
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Henderson, United States, 89052

Status
Completed
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Charlotte, United States, 28207

Status
Completed
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Investigative Site

Seattle, United States, 98101

Status
Completed
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Washington, United States, 20037

Status
Completed
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Louisville, United States, 40202

Status
Completed
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Kansas City, United States, 66160

Status
Completed
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Philadelphia, United States, 19104

Status
Completed
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Indianapolis, United States, 46202

Status
Completed
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San Antonio, United States, 78229

Status
Completed
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Investigative Site

Cullman, United States, 35058

Status
Completed
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Shreveport, United States, 71130

Status
Completed
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Columbus, United States, 43210

Status
Completed
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Investigative Site

Houston, United States, 77030

Status
Completed
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Investigative Site

Providence, United States, 02905

Status
Completed
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Fairfax, United States, 22031

Status
Completed
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Investigative Site

Miami, United States, 33136

Status
Completed
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Investigative Site

Charleston, United States, 29425

Status
Completed
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Investigative Site

Phoenix, United States, 85013

Status
Completed
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Investigative Site

Halifax, Canada, B3H 2Y9

Status
Completed
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Pittsburgh, United States, 15213

Status
Completed
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Cincinnati, United States, 45219

Status
Completed
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La Jolla, United States, 92037

Status
Completed
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Newark, United States, 19713

Status
Completed
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Atlanta, United States, 30309-1465

Status
Completed
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Maitland, United States, 32751

Status
Completed
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Tacoma, United States, 98405

Status
Completed
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Fort Collins, United States, 80528

Status
Completed
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Investigative Site

Hull, Canada, J8Y 1W7

Status
Completed
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Investigative Site

Calgary, Canada, T2N 2T9

Status
Completed
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Investigative Site

Vancouver, Canada, V6T 2B5

Status
Completed
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Investigative Site

Nepean, Canada, K2G 6E2

Status
Completed
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Investigative Site

Nimes, France, 30029

Status
Completed
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Investigative Site

nancy, France, 54035

Status
Completed
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Investigative Site

nice, France, 06000

Status
Completed
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Investigative Site

Ottawa, Canada, K1H 8L6

Status
Completed
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Investigative Site

Montreal, Canada, H3A 2B4

Status
Completed
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Toronto, Canada, M5B 1W8

Status
Completed
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London, Canada, N6A 5A5

Status
Completed
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Investigative Site

Greenfield Park, Canada, J4V 2H1

Status
Completed
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Investigative Site

Mississauga, Canada, L5B 1B8

Status
Completed
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Investigative Site

Lille, France, 59037

Status
Completed
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Investigative Site

Rennes, France, 35038

Status
Completed
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Investigative Site

Dijon, France, 21033

Status
Completed
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Investigative Site

Bordeaux, France, 33076

Status
Completed
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Investigative Site

Nantes, France, 44093

Status
Completed
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Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
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Investigative Site

Malaga, Spain, 29010

Status
Completed
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Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
Locations

Policlinico Consorziale

Bari, Italy, 70122

Status
Terminated
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Investigative Site

Sevilla, Spain, 41071

Status
Completed
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Investigative Site

Firenze, Italy, 50134

Status
Completed
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A.O. di Padova

Padova, Italy, 35128

Status
Completed
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A.O. S.Andrea

Roma, Italy, 00189

Status
Completed
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Investigative Site

Athens, Greece, 11527

Status
Completed
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Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
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Investigative Site

Tampere, Finland, 33521

Status
Completed
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Investigative Site

MELSBROEK, Belgium, 1820

Status
Completed
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Investigative Site

Dublin, Ireland, 9

Status
Completed
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Investigative Site

Dublin, Ireland, 4

Status
Completed
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Investigative Site

Cork, Ireland

Status
Completed
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Investigative Site

Dublin, Ireland

Status
Completed
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Investigative Site

Dresden, Germany, 01307

Status
Completed
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Investigative Site

Marburg, Germany, 35039

Status
Completed
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Investigative Site

Hamburg, Germany, 20246

Status
Completed
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Ospedale San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Terminated
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Investigative Site

Thessaloniki, Greece, 54636

Status
Completed
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Investigative Site

Stockholm, Sweden, 182 88

Status
Completed
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Investigative Site

Bergen, Norway, N-5021

Status
Completed
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Investigative Site

Oulu, Finland, 90029

Status
Completed
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Investigative Site

Brussel, Belgium, 1090

Status
Completed
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Investigative Site

Nijmegen, Netherlands, 6533 PA

Status
Completed
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Investigative Site

Sittard, Netherlands, 6131 BK

Status
Completed
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Investigative Site

Breda, Netherlands, 4819 EV

Status
Completed
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Investigative Site

Hannover, Germany, 30625

Status
Completed
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Investigative Site

Greifswald, Germany, 17475

Status
Completed
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Investigative Site

Hennigsdorf, Germany, 16761

Status
Completed
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Investigative Site

Halle, Germany, 06120

Status
Completed
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Investigative Site

Leipzig, Germany, 04129

Status
Completed
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Investigative Site

Berlin, Germany, 13347

Status
Completed
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Investigative Site

Hamburg, Germany, 20099

Status
Completed
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Investigative Site

Heidelberg, Germany, 69120

Status
Completed
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Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
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Investigative Site

Göttingen, Germany, 37099

Status
Completed
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Investigative Site

Offenbach, Germany, 63069

Status
Completed
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Investigative Site

Essen, Germany, 45117

Status
Completed
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Investigative Site

Innsbruck, Austria, 6020

Status
Completed
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Investigative Site

St. Gallen, Switzerland, 9007

Status
Completed
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Investigative Site

Warszawa, Poland, 02957

Status
Completed
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Investigative Site

Gdansk, Poland, 80-803

Status
Completed
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Investigative Site

Katowice, Poland, 40752

Status
Completed
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Investigative Site

Budapest, Hungary, 1076

Status
Completed
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Investigative Site

Pecs, Hungary, 7623

Status
Completed
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Investigative Site

Budapest, Hungary, 1145

Status
Completed
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Investigative Site

Maribor, Slovenia, 2000

Status
Completed
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Investigative Site

Moskva, Russia, 127018

Status
Completed
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Investigative Site

Bayreuth, Germany, 95445

Status
Completed
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Investigative Site

Gießen, Germany, 35392

Status
Completed
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Investigative Site

Berlin, Germany, 13585

Status
Completed
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Investigative Site

Münster, Germany, 48149

Status
Completed
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Investigative Site

Regensburg, Germany, 93053

Status
Completed
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Investigative Site

Hannover, Germany, 30559

Status
Completed
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Investigative Site

Linz, Austria, 4020

Status
Completed
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Investigative Site

St Poelten, Austria, A-3100

Status
Completed
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Investigative Site

Bern, Switzerland, 3010

Status
Completed
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Investigative Site

Wroclaw, Poland, 50420

Status
Completed
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Investigative Site

Lodz, Poland, 90153

Status
Completed
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Investigative Site

Warszawa, Poland, 02097

Status
Completed
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Investigative Site

Poznan, Poland, 61848

Status
Completed
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Investigative Site

Zalaegerszeg-Pozva, Hungary, H-8900

Status
Completed
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Investigative Site

Györ, Hungary, 9024

Status
Completed
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Investigative Site

Miskolc, Hungary, 3501

Status
Completed
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Investigative Site

Ljubljana, Slovenia, SI-1525

Status
Completed
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Investigative Site

Moskva, Russia, 118089

Status
Completed
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Investigative Site

Nizhy Novgorod, Russia, 603076

Status
Completed
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Investigative Site

Kiev, Ukraine, 03110

Status
Completed
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Investigative Site

Riga, Latvia, LV-1015

Status
Completed
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Investigative Site

Jerusalem, Israel, 91120

Status
Completed
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Investigative Site

Tel Hashomer, Israel, 52621

Status
Completed
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Investigative Site

Haifa, Israel, 31048

Status
Completed
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Investigative Site

Ashkelon, Israel, 78278

Status
Completed
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Investigative Site

Zerifin, Israel, 70300

Status
Completed
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Investigative Site

Rosario, Argentina, S2000ZBL

Status
Completed
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Investigative Site

Buenos Aires, Argentina, C1117ABE

Status
Completed
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Investigative Site

Cordoba, Argentina, X5000HGX

Status
Completed
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Investigative Site

Campinas, Brazil, 13081- 970

Status
Completed
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Investigative Site

Sao Paulo, Brazil, 01221-020

Status
Completed
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Investigative Site

Recife, Brazil, 52010-040

Status
Completed
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Investigative Site

Kogarah, Australia, 2217

Status
Completed
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Investigative Site

Moscow, Russia, 123367

Status
Completed
Locations

Investigative Site

Moskva, Russia, 117049

Status
Completed
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Investigative Site

Sankt-Peterburg, Russia, 197022

Status
Completed
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Investigative Site

St. Petersburg, Russia, 197376

Status
Completed
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Investigative Site

Novosibirsk, Russia, 630007

Status
Completed
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Investigative Site

Moskva, Russia, 129110

Status
Completed
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Investigative Site

Yaroslavl, Russia, 150000

Status
Completed
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Investigative Site

St. Petersburg, Russia, 194044

Status
Completed
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Investigative Site

Donetsk, Ukraine, 83003

Status
Completed
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Investigative Site

Kharkiv, Ukraine, 61068

Status
Completed
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Investigative Site

Lviv, Ukraine, 79000

Status
Completed
Locations

Sourasky Medical Center

Tel-Aviv, Israel, 64239

Status
Completed
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Investigative Site

Rosario, Argentina

Status
Completed
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Investigative Site

Buenos Aires, Argentina, C1416CRJ

Status
Completed
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Investigative Site

Buenos Aires, Argentina, C1280AEB

Status
Completed
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Investigative Site

Sao Paulo, Brazil, 04039-032

Status
Completed
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Investigative Site

Sao Paulo, Brazil, 05403-900

Status
Completed
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Investigative Site

Curitiba, Brazil, 80240-340

Status
Completed
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Investigative Site

Rio de Janeiro, Brazil, 21941-590

Status
Completed
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Investigative Site

Porto Alegre, Brazil, 90035-001

Status
Completed
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Investigative Site

Wyoming, Australia, NSW 2250

Status
Completed
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Investigative Site

Fitzroy, Australia, 3065

Status
Completed
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Investigative Site

Liverpool, Australia, NSW 2170

Status
Completed
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Investigative Site

Parkville, Australia, 3050

Status
Completed

Trial Design