Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
2 other identifiers
interventional
4,125
36 countries
447
Brief Summary
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
Longer than P75 for phase_3
447 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
First Submitted
Initial submission to the registry
September 10, 2010
CompletedStudy Start
First participant enrolled
September 13, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2018
CompletedResults Posted
Study results publicly available
November 7, 2019
CompletedApril 21, 2021
March 1, 2021
8.1 years
September 10, 2010
October 15, 2019
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
Secondary Outcomes (10)
Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod
Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod
Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod
Month 0 (Core Baseline) to End of Study (an average of Month 156)
Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume
Month 3 to End of Study (Study Completion Visit)
Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume
Month 3 to End of Study (Study Completion Visit)
- +5 more secondary outcomes
Study Arms (1)
Fingolimod 0.5 mg/day
EXPERIMENTALOpen-label fingolimod 0.5 mg, taken orally once daily
Interventions
Eligibility Criteria
You may qualify if:
- \- Patients who have completed selected ongoing or planned trials with FTY720.
You may not qualify if:
- Premature permanent discontinuation of a previous fingolimod study.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
- Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
- Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c \> 8%.
- Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
- Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
- Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
- Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
- Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
- Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
- History or presence of a third degree AV block
- Proven history of sick sinus syndrome or sino-atrial heart block
- Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (458)
Novartis Investigative Site
Cullman, Alabama, 35058, United States
Novartis Investigative Site
Oceanside, California, 92056, United States
Novartis Investigative Site
Sacramento, California, 95817, United States
Novartis Investigative Site
San Francisco, California, 94143, United States
Novartis Investigative Site
Washington D.C., District of Columbia, 20007, United States
Novartis Investigative Site
Jacksonville, Florida, 32209, United States
Novartis Investigative Site
Maitland, Florida, 32751, United States
Novartis Investigative Site
Miami, Florida, 33136, United States
Novartis Investigative Site
Sunrise, Florida, 33351, United States
Novartis Investigative Site
Tallahassee, Florida, 32308, United States
Novartis Investigative Site
Tampa, Florida, 33609, United States
Novartis Investigative Site
Vero Beach, Florida, 32960, United States
Novartis Investigative Site
Atlanta, Georgia, 30327, United States
Novartis Investigative Site
Kansas City, Kansas, 66160, United States
Novartis Investigative Site
Lenexa, Kansas, 66212, United States
Novartis Investigative Site
Baltimore, Maryland, 21201, United States
Novartis Investigative Site
Baltimore, Maryland, 21287, United States
Novartis Investigative Site
Kansas City, Missouri, 64111, United States
Novartis Investigative Site
Lebanon, New Hampshire, 03756, United States
Novartis Investigative Site
Albuquerque, New Mexico, 87131-0001, United States
Novartis Investigative Site
New York, New York, 10021, United States
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Durham, North Carolina, 27710, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74136, United States
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Tualatin, Oregon, 97062, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Bristol, Tennessee, 37620, United States
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Nashville, Tennessee, 37212, United States
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San Antonio, Texas, 78229, United States
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Burlington, Vermont, 05401, United States
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Charlottesville, Virginia, 22904, United States
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Seattle, Washington, 98122, United States
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CABA, Buenos Aires, 1425, Argentina
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CABA, Buenos Aires, C1181ACH, Argentina
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CABA, Buenos Aires, C1428AQK, Argentina
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Capital Federal, Buenos Aires, C1192AAW, Argentina
Novartis Investigative Site
Villa Nueva, Mendoza Province, M5507XAD, Argentina
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Salta, Salta Province, A4406BPF, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Córdoba, X5004CDT, Argentina
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Salta, A4400BKZ, Argentina
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Camperdown, New South Wales, 2050, Australia
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Chatswood, New South Wales, 2067, Australia
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Kogarah, New South Wales, 2217, Australia
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Liverpool, New South Wales, 2170, Australia
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North Gosford, New South Wales, 2250, Australia
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Woodville, South Australia, 5011, Australia
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Box Hill, Victoria, 3128, Australia
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Fitzroy, Victoria, 3065, Australia
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Heidelberg, Victoria, 3084, Australia
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Parkville, Victoria, 3050, Australia
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Innsbruck, Tyrol, 6020, Austria
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Linz, A-4020, Austria
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Salzburg, 5020, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1010, Austria
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Vienna, 1090, Austria
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Fraiture En Condroz, Belgium, 4557, Belgium
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Aalst, 9300, Belgium
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Bruges, 8000, Belgium
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Leuven, 3000, Belgium
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Melsbroek, 1820, Belgium
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Overpelt, 3900, Belgium
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Sijsele, 8340, Belgium
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Sint-Truiden, 3800, Belgium
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Wilrijk, 2610, Belgium
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Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil
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Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
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Rio de Janiero, Rio de Janeiro, 20221-161, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Campinas, São Paulo, 13083-970, Brazil
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Ribeirão Preto, São Paulo, 14048-900, Brazil
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Edmonton, Alberta, T6G 2G3, Canada
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Burnaby, British Columbia, V5G 2X6, Canada
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Vancouver, British Columbia, V6T 1Z3, Canada
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Victoria, British Columbia, V8R 1J8, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Kingston, Ontario, K7L 2V7, Canada
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London, Ontario, N6A 5A5, Canada
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Nepean, Ontario, K2G 6E2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Greenfield Park, Quebec, J4V 2J2, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3A 2B4, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Regina, Saskatchewan, S4T 1A5, Canada
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Brno, Czech Republic, 656 91, Czechia
Novartis Investigative Site
Olomouc, CZE, 775 20, Czechia
Novartis Investigative Site
Ostrava-Poruba, 708 00, Czechia
Novartis Investigative Site
Pardubice, 532 03, Czechia
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Plzen - Lochotin, 30460, Czechia
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Prague, 12808, Czechia
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Prague, 150 00, Czechia
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Rychnov nad Kněžnou, 516 01, Czechia
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Teplice, 415 29, Czechia
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Aarhus, DK-8000, Denmark
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Copenhagen, DK-2100, Denmark
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Alexandria, 21131, Egypt
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Cairo, 11566, Egypt
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Cairo, Egypt
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Tallinn, 10617, Estonia
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Helsinki, 00930, Finland
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Seinäjoki, 60220, Finland
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Tampere, 33100, Finland
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Turku, 20520, Finland
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Nancy, Cedex, 54035, France
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Bordeaux, F-33076, France
Novartis Investigative Site
Bron, 69677, France
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Caen, 14033, France
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Clermont-Ferrand, 63003, France
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Dijon, 21034, France
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Lille, 59037, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Nice, 06602, France
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Paris, 75651, France
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Poissy, 78303, France
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Rennes, 35043, France
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Saint-Herblain, 44800, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Ostfildern, Baden-Wurttemberg, 73760, Germany
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Munich, Bavaria, 81241, Germany
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Regensburg, Bavaria, 93053, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Aachen, 52062, Germany
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Aalen, 73430, Germany
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Abensberg, 93326, Germany
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Achim, 28832, Germany
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Alzenau in Unterfranken, 63755, Germany
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Aschaffenburg, 63739, Germany
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Augsburg, 86179, Germany
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Bad Honnef, 53604, Germany
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Bad Krozingen, 79189, Germany
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Bad Mergentheim, 97980, Germany
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Bad Neustadt an der Saale, 97616, Germany
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Bamberg, 96049, Germany
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Bamberg, 96052, Germany
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Bayreuth, 95445, Germany
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Berlin, 10178, Germany
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Berlin, 10625, Germany
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Berlin, 10713, Germany
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Berlin, 10785, Germany
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Berlin, 120999, Germany
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Berlin, 12101, Germany
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Berlin, 12163, Germany
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Berlin, 12351, Germany
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Berlin, 13347, Germany
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Berlin, 13353, Germany
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Berlin, 13439, Germany
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Berlin, 13507, Germany
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Berlin, 14163, Germany
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Bielefeld, 33602, Germany
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Bielefeld, 33611, Germany
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Bielefeld, 33647, Germany
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Bochum, 44787, Germany
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Bochum, 44789, Germany
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Bochum, 44892, Germany
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Bogen, 94327, Germany
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Bonn, 53111, Germany
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Böblingen, 71032, Germany
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Buchholz, 21244, Germany
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Buchholz in der Nordheide, 21244, Germany
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Chemnitz, 09117, Germany
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Cologne, 50935, Germany
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Cologne, 51109, Germany
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Dillingen, 89407, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40211, Germany
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Emden, 26721, Germany
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Emmendingen, 79312, Germany
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Erbach im Odenwald, 64711, Germany
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Erfurt, 99089, Germany
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Erlangen, 91054, Germany
Novartis Investigative Site
Essen, 45131, Germany
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Essen, 45147, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Greifswald, 17475, Germany
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Grevenbroich, 41515, Germany
Novartis Investigative Site
Hamburg, 20099, Germany
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Hamburg, 20249, Germany
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Hamburg, 20354, Germany
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Hamburg, 22083, Germany
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Hanover, 30161, Germany
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Hanover, 30171, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Hennigsdorf, 16761, Germany
Novartis Investigative Site
Herborn, 35745, Germany
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Homburg, 66421, Germany
Novartis Investigative Site
Ibbenbueren, 49477, Germany
Novartis Investigative Site
Itzehoe, 25524, Germany
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Jena, 07743, Germany
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Kaltenkirchen, 24568, Germany
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Kassel, 34121, Germany
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Krefeld, 47805, Germany
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Landshut, 84028, Germany
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Lappersdorf, 93138, Germany
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Leipzig, 04103, Germany
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Leipzig, 04275, Germany
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Lohr a. Main, 79816, Germany
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Ludwigshafen, 67063, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Mannheim, 68159, Germany
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Marburg, 35039, Germany
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München, 80331, Germany
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München, 80377, Germany
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München, 81377, Germany
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München, 81829, Germany
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Münster, 48149, Germany
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Nagold, 72202, Germany
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Neu-Ulm, 89231, Germany
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Neuburg an der Donau, 86633, Germany
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Neuruppin, 16816, Germany
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Oldenburg, 26122, Germany
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Osnabrück, 49076, Germany
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Pforzheim, 75172, Germany
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Potsdam, 14471, Germany
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Prien am Chiemsee, 83209, Germany
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Rostock, 18057, Germany
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Rüdersdorf, 15562, Germany
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Rülzheim, 76761, Germany
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Schwarzenbruck, 90592, Germany
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Schwendi, 88477, Germany
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Siegen, 57076, Germany
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Sinsheim, 74889, Germany
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Stade, 21682, Germany
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Stuttgart, 70174, Germany
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Stuttgart, 70176, Germany
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Stuttgart, 70178, Germany
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Stuttgart, 70182, Germany
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Teupitz, 15755, Germany
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Trier, 54292, Germany
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Tübingen, 72076, Germany
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Ulm, 89073, Germany
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Ulm, 89081, Germany
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Unterhaching, 82008, Germany
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Wendlingen, 73240, Germany
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Wermsdorf, 04779, Germany
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Wiesbaden, 65191, Germany
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Wuppertal, 42283, Germany
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Würzburg, 97070, Germany
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Würzburg, 97080, Germany
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Alexandroupoli, Evros, 681 00, Greece
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Heraklion Crete, Greece, 711 10, Greece
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Athens, GR, 115 25, Greece
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Athens, GR, 115 27, Greece
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Thessaloniki, GR, 570 10, Greece
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Athens, 106 76, Greece
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Athens, 115 21, Greece
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Athens, 11526, Greece
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Athens, 15123, Greece
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Pátrai, 265 00, Greece
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Thessaloniki, 57001, Greece
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Thessaloniki, GR 54636, Greece
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Guatemala City, 01010, Guatemala
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Guatemala City, 01014, Guatemala
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Budapest, HUN, 1204, Hungary
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Budapest, 1076, Hungary
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Budapest, 1085, Hungary
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Budapest, 1115, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7623, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, H-8000, Hungary
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Veszprém, H 8200, Hungary
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Dublin, D04 T6F, Ireland
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Dublin, DUBLIN 9, Ireland
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Ashkelon, 78278, Israel
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Haifa, 3436212, Israel
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Ramat Gan, 52621, Israel
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Sefad, 13100, Israel
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Asti, AT, 14100, Italy
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Acquaviva delle Fonti, BA, 70021, Italy
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Bergamo, BG, 24127, Italy
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Bologna, BO, 40139, Italy
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Montichiari, BS, 25018, Italy
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Cagliari, CA, 09126, Italy
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Chieti, CH, 66100, Italy
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Catania, CT, 95122, Italy
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Catania, CT, 95123, Italy
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Cona, FE, 44100, Italy
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Foggia, FG, 71100, Italy
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Florence, FI, 50134, Italy
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Genova, GE, 16132, Italy
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Pozzilli, IS, 86077, Italy
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Rome, Lazio, 00168, Italy
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Milan, MI, 20122, Italy
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Milan, MI, 20132, Italy
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Palermo, PA, 90146, Italy
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Fidenza, PR, 43036, Italy
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Pavia, PV, 27100, Italy
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Ravenna, RA, 48100, Italy
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Roma, RM, 00133, Italy
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Roma, RM, 00135, Italy
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Roma, RM, 00161, Italy
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Roma, RM, 00189, Italy
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Siena, SI, 53100, Italy
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Orbassano, TO, 10043, Italy
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Udine, UD, 33100, Italy
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Gallarate, VA, 21013, Italy
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Vicenza, VI, 36100, Italy
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Verona, VR, 37134, Italy
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Viterbo, VT, 01100, Italy
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Napoli, 80131, Italy
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Napoli, 80132, Italy
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Napoli, 80138, Italy
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Irbid, 22110, Jordan
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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Breda, CK, 4818, Netherlands
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Amsterdam, 1061 AE, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Blaricum, 1261 AN, Netherlands
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Enschede, 7513 ER, Netherlands
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Gouda, 2803 HH, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, 6525 GC, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Sittard-Geleen, 6162 BG, Netherlands
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Tilburg, 5022 GC, Netherlands
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Lillehammer, 2629, Norway
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Molde, 6412, Norway
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Stavanger, 4068, Norway
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Panama City, 0801, Panama
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Panama City, Panama
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Jesus Maria, Lima region, 11, Peru
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San Isidro, Lima region, 27, Peru
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La Perla, Provincia Constitucional del Callao, 04, Peru
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Related Publications (1)
Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.
PMID: 31598139DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 14, 2010
Study Start
September 13, 2010
Primary Completion
October 19, 2018
Study Completion
October 19, 2018
Last Updated
April 21, 2021
Results First Posted
November 7, 2019
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com