Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
ATMOSPHERE
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
2 other identifiers
interventional
7,064
41 countries
769
Brief Summary
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
Longer than P75 for phase_3
769 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
February 26, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 25, 2016
CompletedNovember 25, 2016
October 1, 2016
6.6 years
February 26, 2009
October 3, 2016
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
up to End of Study (78 months)
Secondary Outcomes (2)
Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Baseline, Month 12
All Cause Death
up to end of study (78 months)
Study Arms (3)
Combination Aliskiren / Enalapril
EXPERIMENTALAliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
Aliskiren
EXPERIMENTALAliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
Enalapril
ACTIVE COMPARATOREnalapril monotherapy -10 mg film-coated tablet and administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years of age, male or female.
- Patients with a diagnosis of chronic heart failure (NYHA
- Class II - IV):
- LVEF ≤ 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)
- Elevated BNP or NT-proBNP at Visit 1:
- BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
- Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
- Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
- Written informed consent to participate in the study and ability to comply with all requirements.
You may not qualify if:
- Patients with any of the following were to be excluded from participation in the study:
- History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
- Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
- Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
- Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
- Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
- Right heart failure due to severe pulmonary disease.
- Patients with Diabetes Mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (806)
Novartis Investigative Site
Huntsville, Alabama, 35801, United States
Novartis Investigative Site
Mobile, Alabama, 36608, United States
Novartis Investigative Site
Mobile, Alabama, 36693, United States
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Tucson, Arizona, 85723-0001, United States
Novartis Investigative Site
Hot Springs, Arkansas, 71913, United States
Novartis Investigative Site
Little Rock, Arkansas, 72204, United States
Novartis Investigative Site
Little Rock, Arkansas, 72205, United States
Novartis Investigative Site
Pine Bluff, Arkansas, 71603, United States
Novartis Investigative Site
Searcy, Arkansas, 72143, United States
Novartis Investigative Site
Beverly Hills, California, 90211, United States
Novartis Investigative Site
French Camp, California, 95231, United States
Novartis Investigative Site
Inglewood, California, 90301, United States
Novartis Investigative Site
Los Angeles, California, 90073, United States
Novartis Investigative Site
Modesto, California, 95355, United States
Novartis Investigative Site
Northridge, California, 91325, United States
Novartis Investigative Site
Sacramento, California, 95825, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
Santa Monica, California, 90404, United States
Novartis Investigative Site
Westlake Village, California, 91361, United States
Novartis Investigative Site
Denver, Colorado, 80218, United States
Novartis Investigative Site
Littleton, Colorado, 80120, United States
Novartis Investigative Site
Boynton Beach, Florida, 33437, United States
Novartis Investigative Site
Daytona Beach, Florida, 32117, United States
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Fort Lauderdale, Florida, 33316, United States
Novartis Investigative Site
Hollywood, Florida, 33021, United States
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Jacksonville Beach, Florida, 32050, United States
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Miami Lakes, Florida, 33014, United States
Novartis Investigative Site
Orlando, Florida, 32803, United States
Novartis Investigative Site
Wellington, Florida, 33449, United States
Novartis Investigative Site
Athens, Georgia, 30606, United States
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Augusta, Georgia, 30904, United States
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Gillespie, Illinois, 62033, United States
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Topeka, Kansas, 66606, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70121, United States
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Slidell, Louisiana, 70458, United States
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Auburn, Maine, 04210, United States
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Southfield, Michigan, 48075, United States
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St Louis, Missouri, 63110, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68198, United States
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Elmer, New Jersey, 08318, United States
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Laurelton, New York, 11422, United States
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Stony Brook, New York, 11794, United States
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Wiliamsville, New York, 14221, United States
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Durham, North Carolina, 27710, United States
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Marion, Ohio, 43302, United States
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Charleston, South Carolina, 29403, United States
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Varnville, South Carolina, 29944, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37205, United States
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Nashville, Tennessee, 37212, United States
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Dallas, Texas, 75226, United States
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Houston, Texas, 77021, United States
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Houston, Texas, 77030, United States
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Everett, Washington, 98208, United States
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Kirkland, Washington, 98034, United States
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Bahía Blanca, Buenos Aires, 8000, Argentina
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Buenos Aires, Buenos Aires, C1094AAD, Argentina
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Buenos Aires, Buenos Aires, C1428DCO, Argentina
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Caba, Buenos Aires, C1180AAX, Argentina
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Caba, Buenos Aires, C1408INH, Argentina
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Caba, Buenos Aires, C1416DRJ, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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Ramos Mejía, Buenos Aires, B1704ETD, Argentina
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San Isidro, Buenos Aires, B1642DCD, Argentina
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San Nicolás de los Arroyos, Buenos Aires, B2900DMH, Argentina
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Corrientes, Corrientes Province, W3400CBI, Argentina
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Corrientes, Corrientes Province, W3400, Argentina
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Córdoba, Córdoba Province, X5000AAI, Argentina
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Córdoba, Córdoba Province, X5000AVI, Argentina
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Córdoba, Córdoba Province, X5000EPU, Argentina
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Córdoba, Córdoba Province, X5000EVQ, Argentina
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Córdoba, Córdoba Province, X5000FGG, Argentina
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Córdoba, Córdoba Province, X5002AOQ, Argentina
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Córdoba, Córdoba Province, X5003DCE, Argentina
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Córdoba, Córdoba Province, X5004BAL, Argentina
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Córdoba, Córdoba Province, X5006IKK, Argentina
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Córdoba, Córdoba Province, X5009BSN, Argentina
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Córdoba, Córdoba Province, X5022CPU, Argentina
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Córdoba, Córdoba Province, X5152HQC, Argentina
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Córdoba, Córdoba Province, X5220XAO, Argentina
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Va Allende, Córdoba Province, 5105, Argentina
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Villa María, Córdoba Province, X5220XAO, Argentina
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Posadas, Misiones Province, N3300AHX, Argentina
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Salta, Salta Province, 4400, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina
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Rosario, Santa Fe Province, S2000CXH, Argentina
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Rosario, Santa Fe Province, S2000DFD, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2001ODA, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Canberra, Australian Capital Territory, 2605, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Kingswood, New South Wales, 2747, Australia
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Wollongong, New South Wales, 2500, Australia
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Auchenflower, Queensland, 4066, Australia
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Woolloongabba, Queensland, 4101, Australia
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Wooloongabba, Queensland, 4102, Australia
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Bedford Park, South Australia, 5042, Australia
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Launceston, Tasmania, 7250, Australia
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Geelong, Victoria, 3220, Australia
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Prahran, Victoria, 3181, Australia
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Graz, Austria, A-8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Linz, 4010, Austria
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Linz, A-4010, Austria
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Salzburg, A-5020, Austria
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Vienna, 1030, Austria
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Vienna, 1140, Austria
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Vienna, A-1090, Austria
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Vienna, A-1160, Austria
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Brussels, Belgium, 1180, Belgium
Novartis Investigative Site
Anderlecht, 1070, Belgium
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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De Pinte, 9840, Belgium
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Eupen, 4700, Belgium
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Genk, 3600, 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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Liège, 4000, Belgium
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Turnhout, 2300, Belgium
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Fortaleza, Ceará, 60864-190, Brazil
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Brasília, Federal District, 70658-700, Brazil
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Goiânia, Goiás, 74605-050, Brazil
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Belo Horizonte, Minas Gerais, 30110-934, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Campina Grande do Sul, Paraná, 83430-000, Brazil
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Curitiba, Paraná, 80010-030, Brazil
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Londrina, Paraná, 86051-990, Brazil
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Recife, Pernambuco, 50100-060, Brazil
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Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil
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Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Novartis Investigative Site
Campinas, São Paulo, 13020-431, Brazil
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Campinas, São Paulo, 13060-904, Brazil
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Campinas, São Paulo, 13083-190, Brazil
Novartis Investigative Site
Marília, São Paulo, 17519-030, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 05403-900, Brazil
Novartis Investigative Site
Tatuí, São Paulo, 18270-170, Brazil
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Brampton, Ontario, L6Z 4N5, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Joliette, Quebec, J6E 6J2, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H1T 3Y7, Canada
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Québec, Quebec, G1J 1Z6, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, 100083, China
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Beijing, Beijing Municipality, 100088, China
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Beijing, Beijing Municipality, 100730, China
Novartis Investigative Site
Fuzhou, Fujian, 350001, China
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510515, China
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Shijiazhuang, Hebei, 050000, China
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Wuhan, Hubei, 430022, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, 215004, China
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Changchun, Jilin, 130021, China
Novartis Investigative Site
Shenyang, Liaoning, 110003, China
Novartis Investigative Site
Shenyang, Liaoning, 110016, China
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Shanghai, Shanghai Municipality, 200011, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310009, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310013, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
Novartis Investigative Site
Baotou, 014040, China
Novartis Investigative Site
Beijing, 100020, China
Novartis Investigative Site
Beijing, 100028, China
Novartis Investigative Site
Beijing, 100029, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100044, China
Novartis Investigative Site
Beijing, 100050, China
Novartis Investigative Site
Guangzhou, 510080, China
Novartis Investigative Site
Jinan, 250012, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Shanghai, 200032, China
Novartis Investigative Site
Shanghai, 200233, China
Novartis Investigative Site
Tianjin, 300142, China
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Xi'an, 710004, China
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Medellín, Antioquia, Colombia
Novartis Investigative Site
Baranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, 111411, Colombia
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Bogotá, Cundinamarca, 110111, Colombia
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Cartagena, Departamento de Bolívar, Colombia
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Barranquilla, Colombia
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Bogotá, 00000, Colombia
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Bogotá, Colombia
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Florida Blanca, Colombia
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Medellín, Colombia
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Alajuela, Costa Rica, Costa Rica
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San José, Costa Rica, 1307-1000, Costa Rica
Novartis Investigative Site
San José, Costa Rica, 272-1225, Costa Rica
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Guadalupe, San Jose, Costa Rica, 3184-1000, Costa Rica
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Benešov, Czech Republic, 25601, Czechia
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Brno, Czech Republic, 60200, Czechia
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Český Krumlov, Czech Republic, 381 01, Czechia
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Jindřichův Hradec, Czech Republic, 377 01, Czechia
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Kolín, Czech Republic, 280 02, Czechia
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Kroměříž, Czech Republic, 767 01, Czechia
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Louny, Czech Republic, 440 01, Czechia
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Louny, Czech Republic, Czechia
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Ostrava, Czech Republic, 70200, Czechia
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Pilsen, Czech Republic, 323 00, Czechia
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Prague, Czech Republic, 148 00, Czechia
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Prague, Czech Republic, Czechia
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Teplice, Czech Republic, 415 01, Czechia
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Vyškov, Czech Republic, 68001, Czechia
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Mariánské Lázně, 353 01, Czechia
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Prague, 128 08, Czechia
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Pribram VIII, 261 01, Czechia
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Aalborg, Denmark, DK-9000, Denmark
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Hellerup, Denmark, DK-2900, Denmark
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Hvidovre, Denmark, DK-2650, Denmark
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Silkeborg, Denmark, 8600, Denmark
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Århus N, DK-8200, Denmark
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Copenhagen, 2100, Denmark
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Copenhagen NV, DK-2400, Denmark
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Copenhagen S, DK-2300, Denmark
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Elsinore, DK-3000, Denmark
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Esbjerg, DK-6700, Denmark
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Fredericia, 7000, Denmark
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Frederiksberg, DK-2000, Denmark
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Glostrup Municipality, DK-2600, Denmark
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Hillerød, DK-3400, Denmark
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Hjørring, DK-9800, Denmark
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Holbæk, DK-4300, Denmark
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Køge, DK-4600, Denmark
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Næstved, DK-4700, Denmark
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Odense C, DK-5000, Denmark
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Randers NØ, DK-8930, Denmark
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Svendborg, DK-5700, Denmark
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Viborg, DK-8800, Denmark
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Santo Domingo, Republica Dominicana, Dominican Republic
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San Cristóbal, San Cristóbal, Dominican Republic
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Tallinn, Estonia, 10138, Estonia
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Pärnu, 80010, Estonia
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Seinäjoki, Finland, 60200, Finland
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Ekenäs, 10600, Finland
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Hyvinkää, FIN-05850, Finland
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Jyväskylä, FIN-40620, Finland
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Turku, FIN-20520, Finland
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Albi, 81013, France
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Angers, 49000, France
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Bécon-les-Granits, 49370, France
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Clichy, 92110, France
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Dijon, 21079, France
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Grenoble, 38043, France
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Marseille, 13385, France
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Marseille, 13915, France
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Paris, 75013, France
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Paris, 75571, France
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Pessac, 33604, France
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Saint-Etienne, 42055, France
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Vandœuvre-lès-Nancy, 54511, France
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Göttingen, Germany, 37073, Germany
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Winsen, Lower Saxony, 21423, Germany
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Augsburg, 86150, Germany
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Bad Nauheim, 61231, Germany
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Bad Neustadt an der Saale, 97616, Germany
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Bensheim, 64625, Germany
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Berlin, 10367, Germany
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Berlin, 10789, Germany
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Berlin, 12163, Germany
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Berlin, 12351, Germany
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Berlin, 12552, Germany
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Berlin, 13353, Germany
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Berlin, 13405, Germany
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Bochum, 44791, Germany
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Bonn, 53115, Germany
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Bonn, 53127, Germany
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Bonn, 53225, Germany
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Brake, 26919, Germany
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Celle, 29223, Germany
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Chemnitz, 09113, Germany
Novartis Investigative Site
Chemnitz, 09116, Germany
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Chemnitz, 09126, Germany
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Coburg, 96450, Germany
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Cologne, 51605, Germany
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Darmstadt, 64283, Germany
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Dessau, 06846, Germany
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Dinkelsbühl, 91550, Germany
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Dorsten, 46282, Germany
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Dortmund, 44137, Germany
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Dresden, 01067, Germany
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Dresden, 01097, Germany
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Dresden, 01219, Germany
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Dresden, 01277, Germany
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Dresden, 01309, Germany
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Duisburg, 47051, Germany
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Duisburg, 47139, Germany
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Düsseldorf, 40593, Germany
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Ebersbach, 02730, Germany
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Erfurt, 99084, Germany
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Erkner, 15537, Germany
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Essen, 45136, Germany
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Essen, 45355, Germany
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Frankfurt, 60594, Germany
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Gotha, 99867, Germany
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Göttingen, 37075, Germany
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Gütersloh, 33332, Germany
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Halle, 06120, Germany
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Hamburg, 20099, Germany
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Hanover, 30167, Germany
Novartis Investigative Site
Haßloch, 67454, Germany
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Heidelberg, 69115, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Helmbrechts, 95223, Germany
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Heppenheim an der Bergstrasse, 64646, Germany
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Kassel, 34127, Germany
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Kleve, 47533, Germany
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Koblenz, 56068, Germany
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Königsbrück, 01436, Germany
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Köthen, 06366, Germany
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Krefeld, 47798, Germany
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Lambrecht, 67466, Germany
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Landshut, 84034, Germany
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Leipzig, 04177, Germany
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Lichtentanne, 08115, Germany
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Lienen, 49536, Germany
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Loerrach, 79539, Germany
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Ludwigsburg, 71634, Germany
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Lüneburg, 21339, Germany
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Magdeburg, 39110, Germany
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Mainz, 55116, Germany
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Markkleeberg, 04416, Germany
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Mayen, 56727, Germany
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Melsungen, 34212, Germany
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Muehldorf Am Inn, 84453, Germany
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Muehlheim An Der Ruhr, 45468, Germany
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Mülheim, 45468, Germany
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München, 80636, Germany
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Northeim, 37154, Germany
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Nuremberg, 90471, Germany
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Oelde, 59302, Germany
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Oelde, 59303, Germany
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Pirna, 01796, Germany
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Potsdam, 14471, Germany
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Reinfeld, 23858, Germany
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Salzwedel, 29410, Germany
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Schwalmstadt, 34613, Germany
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Schwäbisch Hall, 74523, Germany
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Siegen, 57072, Germany
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Solingen, 42651, Germany
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Stade, 21682, Germany
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Stuttgart, 70372, Germany
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Stuttgart, 70378, Germany
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Wedel, 22880, Germany
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Witten, 58455, Germany
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Würzburg, 97078, Germany
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Zwickau, 08056, Germany
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Athens, Greece, 124 62, Greece
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Athens, Greece, GR 11527, Greece
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Athens, GR, 115 27, Greece
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Thessaloniki, GR, 546 36, Greece
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Thessaloniki, GR, 570 10, Greece
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Athens, 115 28, Greece
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Chios, 82100, Greece
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Edessa, 58200, Greece
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Guntur, Andhra Pradesh, 522001, India
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Hyderabad, Andhra Pradesh, 500012, India
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Secunderabad, Andhra Pradesh, 500003, India
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Vijayawada, Andhra Pradesh, 520 008, India
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Ahmedabad, Gujarat, 380 051, India
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Lucknow, India, 226003, India
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Mumbai, India, 400 050, India
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Noida, India, 201301, India
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Bangalore, Karnataka, 560 052, India
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Bangalore, Karnataka, 560099, India
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Manipal, Karnataka, 576104, India
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Trivandrum, Kerala, 695002, India
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Mumbai, Maharashtra, 400 022, India
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Nagpur, Maharashtra, 400 008, India
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Nagpur, Maharashtra, 400 012, India
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Nagpur, Maharashtra, 400012, India
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Nagpur, Maharashtra, 440 010, India
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Nagpur, Maharashtra, 440010, India
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Nagpur, Maharashtra, 440012, India
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Pune, Maharashtra, 411 011, India
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Pune, Maharashtra, 411 019, India
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Pune, Maharashtra, 411 044, India
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Pune, Maharashtra, 411004, India
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Pune, Maharashtra, 411011, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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Delhi, New Delhi, 110065, India
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New Delhi, New Delhi, 110044, India
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Jaipur, Rajasthan, 302001, India
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Jaipur, Rajasthan, 302024, India
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Chennai, Tamil Nadu, 600100, India
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Coimbatore, Tamil Nadu, 641014, India
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Madurai, Tamil Nadu, 625107, India
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Hyderabad, Telangana, 500082, India
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Lucknow, Uttar Pradesh, 226005, India
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Lucknow, Uttar Pradesh, 226014, India
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Bangalore, 560 034, India
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Hyderabad, 500 063, India
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Hyderabad, 500044, India
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Co Dublin, Ireland, Ireland
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Galway, Ireland, Ireland
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Dublin, 9, Ireland
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Dublin, Ireland
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Montescano, (pv), 27040, Italy
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Pavia, (pv), 27100, Italy
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Ancona, AN, 60126, Italy
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Arezzo, AR, 52100, Italy
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Cortona, AR, 52044, Italy
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Bergamo, BG, 24128, Italy
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Bologna, BO, 40138, Italy
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Brescia, BS, 25123, Italy
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Lumezzane, BS, 25065, Italy
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Chieti, CH, 66100, Italy
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Cosenza, CS, 87100, Italy
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Forlì, FC, 47100, Italy
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Cona, FE, 44100, Italy
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Foggia, FG, 71100, Italy
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Florence, FI, 50143, Italy
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Pozzilli, IS, 86077, Italy
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Casarano, LE, 73042, Italy
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Cecina, LI, 57023, Italy
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Castelnuovo di Garfagnana, LU, 55032, Italy
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Milan, MI, 20132, Italy
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Milan, MI, 20138, Italy
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Passirana Di Rho, MI, 20017, Italy
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Pieve di Coriano, MN, Italy
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Massa, MS, 54100, Italy
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Palermo, PA, 90127, Italy
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Perugia, PG, 06129, Italy
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Parma, PR, 43100, Italy
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Pavia, PV, 27100, Italy
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Cotignola, RA, 48010, Italy
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Roma, RM, 00169, Italy
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Roma, RM, 00184, Italy
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Roma, RM, 00189, Italy
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Rimini, RN, 47900, Italy
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Cava de' Tirreni, SA, 84013, Italy
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Poggibonsi, SI, 53036, Italy
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Sondalo, SO, 23035, Italy
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Sarzana, SP, 19038, Italy
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Sassari, SS, 07100, Italy
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Orbassano, TO, 10043, Italy
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Torino, TO, 10126, Italy
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Terni, TR, 05100, Italy
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Trieste, TS, 34142, Italy
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Trieste, TS, 34149, Italy
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Vittorio Veneto, TV, 31029, Italy
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San Daniele del Friuli, UD, 33038, Italy
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Udine, UD, 33100, Italy
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Tradate, VA, 21049, Italy
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San Bonifacio, VR, 37047, Italy
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Nagoya, Aichi-ken, 466-8560, Japan
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Seto, Aichi-ken, 489-8642, Japan
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Chiba, Chiba, 260-8677, Japan
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Inba-gun, Chiba, 270-1694, Japan
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Chikushino-shi, Fukuoka, 818-8502, Japan
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Fukuoka, Fukuoka, 814-0180, Japan
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Iizuka, Fukuoka, 820-8505, Japan
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Kurume, Fukuoka, 830-8577, Japan
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Fukushima, Fukushima, 960-8251, Japan
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Ōgaki, Gifu, 503-8502, Japan
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Hiroshima, Hiroshima, 734-8551, Japan
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Kure, Hiroshima, 737-0023, Japan
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Sapporo, Hokkaido, 060-8648, Japan
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Sapporo, Hokkaido, 063-0005, Japan
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Amagasaki, Hyōgo, 660-8550, Japan
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Higashiibaraki-gun, Ibaraki, 311-3193, Japan
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Hitachi-Naka, Ibaraki, 312-0057, Japan
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Tsukuba, Ibaraki, 305-8576, Japan
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Kanazawa, Ishikawa-ken, 920-8650, Japan
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Kawasaki, Kanagawa, 210-0852, Japan
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Sagamihara, Kanagawa, 252-0375, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Yokosuka, Kanagawa, 238-8567, Japan
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Kumamoto, Kumamoto, 860-8556, Japan
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Sendai, Miyagi, 980-8574, Japan
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Nagasaki, Nagasaki, 850-8555, Japan
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Kashihara, Nara, 634-8522, Japan
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Okayama, Okayama-ken, 702-8055, Japan
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Izumisano, Osaka, 598-8577, Japan
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Kita-ku, Osaka, 530-0001, Japan
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Osaka, Osaka, 545-8586, Japan
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Saga, Saga-ken, 849-8501, Japan
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Ureshino, Saga-ken, 843-0393, Japan
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Hamada, Shimane, 697-8511, Japan
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Komatsushimachō, Tokushima, 773-8502, Japan
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Tokushima, Tokushima, 770-8503, Japan
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Adachi-ku, Tokyo, 120-0006, Japan
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Bunkyo-ku, Tokyo, 113-8431, Japan
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Bunkyo-ku, Tokyo, 113-8519, Japan
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Bunkyo-ku, Tokyo, 113-8603, Japan
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Bunkyo-ku, Tokyo, 113-8655, Japan
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Shinjuku-ku, Tokyo, 162-8666, Japan
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Toyama, Toyama, 930-0194, Japan
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Hōfu, Yamaguchi, 747-8511, Japan
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Shūnan, Yamaguchi, 745-8522, Japan
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Ube, Yamaguchi, 755-8505, Japan
Novartis Investigative Site
Daugavpils, LV-5401, Latvia
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Riga, 1012, Latvia
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Riga, LV-1012, Latvia
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Riga, LV-1038, Latvia
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Kaunas, LTU, 50009, Lithuania
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Kaunas, LT-47144, Lithuania
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Klaipėda, LT-92288, Lithuania
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Vilnius, 08661, Lithuania
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Aguascalientes, Aguascalientes, 20230, Mexico
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Guadalajara, Jalisco, 44600, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Monterrey, Nuevo León, 64060, Mexico
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Monterrey, Nuevo León, 64710, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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San Luis Potosí City, San Luis Potosí, 78200, Mexico
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Culiacán, Sinaloa, CP:83230, Mexico
Novartis Investigative Site
Enschede, Netherlands, 7513 ER, Netherlands
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Zutphen, Netherlands, 7207 AE, Netherlands
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Alkmaar, 1815 JD, Netherlands
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Amsterdam, 1023 NL, Netherlands
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Amsterdam, 1061 AE, Netherlands
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Amsterdam, 1091 HA, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Deventer, 7416 SE, Netherlands
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Dirksland, 3247 BW, Netherlands
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Groningen, 9713 GZ, Netherlands
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Haarlem, 2035 RC, Netherlands
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Heerlen, 6419 PC, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Leiderdorp, NL-2353 GA, Netherlands
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Meppel, 7943 KA, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Venlo, 5912 BL, Netherlands
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Wildervank, 9648 BE, Netherlands
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Zwolle, 8011 JW, Netherlands
Novartis Investigative Site
Oslo, 0514, Norway
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Trondheim, 7006, Norway
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Tønsberg, 3116, Norway
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Trujillo, La Libertad, Peru
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Chiclayo, Lambayeque, Peru
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Lima, Lima Province, Lima 39, Peru
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Bellavista, Lima region, Callao 02, Peru
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Jesus Maria, Lima region, 11, Peru
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Lima Cercado, Lima region, 01, Peru
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Miraflores, Lima region, 18, Peru
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San Borja, Lima region, 41, Peru
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San Isidro, Lima region, 27, Peru
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San Juan de Miraflores, Lima region, 29, Peru
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Bytom, 41-902, Poland
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Chorzów, 41-506, Poland
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Gdansk, 80-180, Poland
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Gdynia, 81-423, Poland
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Gdynia, 81-519, Poland
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Gliwice, 44-100, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Katowice, 40-040, Poland
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Katowice, 40-084, Poland
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Krakow, 30-053, Poland
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Krakow, 31-501, Poland
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Kłodzko, 57-300, Poland
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Opole, 45-706, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Oława, 55-200, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 61-485, Poland
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Płock, 09-402, Poland
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Sandomierz, 27-600, Poland
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Tarnów, 33-100, Poland
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Torun, 87-100, Poland
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Warsaw, 03-242, Poland
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Warsaw, 04-628, Poland
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Wroclaw, 50-349, Poland
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Wroclaw, 50-420, Poland
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Wroclaw, 50-981, Poland
Novartis Investigative Site
Wroclaw, 52-612, Poland
Novartis Investigative Site
Zabrze, 41-800, Poland
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Łomża, 18-104, Poland
Novartis Investigative Site
Amadora, Portugal, 2720-276, Portugal
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Carnaxide, Portugal, 2799-523, Portugal
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Coimbra, Portugal, 3000-075, Portugal
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Lisbon, Portugal, 1495-005, Portugal
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Lisbon, Portugal, 1600-190, Portugal
Novartis Investigative Site
Lisbon, Portugal, 1769-001, Portugal
Novartis Investigative Site
Penafiel, Portugal, 4564-007, Portugal
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Porto, Portugal, 4200-319, Portugal
Novartis Investigative Site
Aveiro, 3814-501, Portugal
Novartis Investigative Site
Faro, 8000-386, Portugal
Novartis Investigative Site
Humacao, 00791, Puerto Rico
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Ponce, 00717, Puerto Rico
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San Juan, 00936-6528, Puerto Rico
Novartis Investigative Site
Bucharest, District 1, 012051, Romania
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Bucharest, District 1, 012064, Romania
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Bucharest, District 2, 021705, Romania
Novartis Investigative Site
Iași, Jud Iasi, 700005, Romania
Novartis Investigative Site
Târgu Mureş, Jud Mures, 540043, Romania
Novartis Investigative Site
Iași, Jud. Iasi, 700506, Romania
Novartis Investigative Site
Târgu Mureş, Mureș County, 540136, Romania
Novartis Investigative Site
Brasov, Romania, 500281, Romania
Novartis Investigative Site
Brasov, Romania, 500427, Romania
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Oradea, Romania, 410169, Romania
Novartis Investigative Site
Timișoara, Romania, 300736, Romania
Novartis Investigative Site
Baia Mare, 430123, Romania
Novartis Investigative Site
Cluj-Napoca, 400006, Romania
Novartis Investigative Site
Cluj-Napoca, 400347, Romania
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Iași, 700547, Romania
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Piteşti, 110114, Romania
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Târgu Mureş, 540096, Romania
Novartis Investigative Site
Timișoara, 300310, Romania
Novartis Investigative Site
Barnaul, 656055, Russia
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Chelyabinsk, 454000, Russia
Novartis Investigative Site
Chelyabinsk, 454021, Russia
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Chelyabinsk, 454047, Russia
Novartis Investigative Site
Chelyabinsk, 454048, Russia
Novartis Investigative Site
Izhevsk, 426009, Russia
Novartis Investigative Site
Kirov, 610014, Russia
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Krasnodar, 350063, Russia
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Kursk, 305035, Russia
Novartis Investigative Site
Lyubertsy, 140006, Russia
Novartis Investigative Site
Moscow, 105229, Russia
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Moscow, 111020, Russia
Novartis Investigative Site
Moscow, 111539, Russia
Novartis Investigative Site
Moscow, 115432, Russia
Novartis Investigative Site
Moscow, 117292, Russia
Novartis Investigative Site
Moscow, 119992, Russia
Novartis Investigative Site
Moscow, 121359, Russia
Novartis Investigative Site
Moscow, 127473, Russia
Novartis Investigative Site
Moscow, 129301, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Nizhny Novgorod, 603018, Russia
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Novosibirsk, 630047, Russia
Novartis Investigative Site
Novosibirsk, 630075, Russia
Novartis Investigative Site
Novosibirsk, 630089, Russia
Novartis Investigative Site
Omsk, 644018, Russia
Novartis Investigative Site
Perm, 614097, Russia
Novartis Investigative Site
Pushkin,St-Petersburg, 196601, Russia
Novartis Investigative Site
Ryazan, 390026, Russia
Novartis Investigative Site
S.-Petersburg, 196247, Russia
Novartis Investigative Site
Saint Petersburg, 191119, Russia
Novartis Investigative Site
Saint Petersburg, 194044, Russia
Novartis Investigative Site
Saint Petersburg, 197022, Russia
Novartis Investigative Site
Saint Petersburg, 197341, Russia
Novartis Investigative Site
Saint Petersburg, 198013, Russia
Novartis Investigative Site
Saratov, 410012, Russia
Novartis Investigative Site
Saratov, 410028, Russia
Novartis Investigative Site
Tyumen, 625026, Russia
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Volgograd, 400001, Russia
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Volgograd, 400008, Russia
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Voronezh, 394065, Russia
Novartis Investigative Site
Yaroslavl, 150000, Russia
Novartis Investigative Site
Yaroslavl, 150030, Russia
Novartis Investigative Site
Yaroslavl, 150062, Russia
Novartis Investigative Site
Yekaterinburg, 620028, Russia
Novartis Investigative Site
Yekaterinburg, 620137, Russia
Novartis Investigative Site
Bratislava, Slovak Republic, 812 72, Slovakia
Novartis Investigative Site
Bratislava, Slovak Republic, 826 06, Slovakia
Novartis Investigative Site
Komárno, Slovak Republic, 94575, Slovakia
Novartis Investigative Site
Košice, Slovak Republic, 040 01, Slovakia
Novartis Investigative Site
Košice, Slovak Republic, 04166, Slovakia
Novartis Investigative Site
Levice, Slovak Republic, 93401, Slovakia
Novartis Investigative Site
Nitra, Slovak Republic, 949 01, Slovakia
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Považská Bystrica, Slovak Republic, 01701, Slovakia
Novartis Investigative Site
Prešov, Slovak Republic, 08101, Slovakia
Novartis Investigative Site
Stropkov, Slovak Republic, 09101, Slovakia
Novartis Investigative Site
Žilina, Slovak Republic, 010 01, Slovakia
Novartis Investigative Site
Žilina, Slovak Republic, 08001, Slovakia
Novartis Investigative Site
Bardejov, Slovakia, 085 01, Slovakia
Novartis Investigative Site
Košice, Slovakia, 040 01, Slovakia
Novartis Investigative Site
Košice, Slovakia, 04001, Slovakia
Novartis Investigative Site
Lučenec, Slovakia, 98439, Slovakia
Novartis Investigative Site
Prešov, Slovakia, 080 01, Slovakia
Novartis Investigative Site
Trebišov, Slovakia, 075 01, Slovakia
Novartis Investigative Site
Trenčín, Slovakia, 911 01, Slovakia
Novartis Investigative Site
Bratislava, 81369, Slovakia
Novartis Investigative Site
Piešťany, 921 01, Slovakia
Novartis Investigative Site
Žilina, 012 07, Slovakia
Novartis Investigative Site
Soweto, Gauteng, 2013, South Africa
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Benoni, South Africa
Novartis Investigative Site
Boksburg, South Africa
Novartis Investigative Site
Centurion, 4001, South Africa
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Johannesburg, 2157, South Africa
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Western Cape, 7130, South Africa
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Worcester, 6850, South Africa
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Gwangju, Gwangju, 501-757, South Korea
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Seongnam-si, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Seoul, Korea, 03080, South Korea
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Seoul, Korea, 03722, South Korea
Novartis Investigative Site
Seoul, Korea, 05505, South Korea
Novartis Investigative Site
Seoul, Korea, 06351, South Korea
Novartis Investigative Site
Seoul, Korea, 152-703, South Korea
Novartis Investigative Site
Busan, 602-715, South Korea
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Daejeon, 302-241, South Korea
Novartis Investigative Site
Incheon, 405-760, South Korea
Novartis Investigative Site
Seoul, 143-729, South Korea
Novartis Investigative Site
Taegu, 700 - 721, South Korea
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
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Utrera, Andalusia, 41710, Spain
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Barcelona, Barcelona, 08041, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Villamartín, Cadiz, 11650, Spain
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Badalona, Catalonia, 08916, Spain
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Barcelona, Catalonia, 08035, Spain
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Barcelona, Catalonia, 08036, Spain
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Tarragona, Catalonia, 43005, Spain
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Tortosa, Catalonia, 43500, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28049, Spain
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Majadahonda, Madrid, 28222, Spain
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Valdemoro, Madrid, 28342, Spain
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Alicante, Valencia, 03004, Spain
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Valencia, Valencia, 46014, Spain
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Malmo, Sweden, SE 211 36, Sweden
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Nässjö, Sweden, SE 571 31, Sweden
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Falun, 791 82, Sweden
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Gothenburg, 416 85, Sweden
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Karlstad, 681 85, Sweden
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Linköping, 581 85, Sweden
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Lund, SE-222 21, Sweden
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Malmo, 205 02, Sweden
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Malmo, 214 22, Sweden
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Mölndal, 431 80, Sweden
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Örebro, 701 85, Sweden
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Skellefteå, 931 86, Sweden
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Stockholm, 111 57, Sweden
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Stockholm, 112 81, Sweden
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Stockholm, 17176, Sweden
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Stockholm, SE-111 35, Sweden
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Sundsvall, 851 86, Sweden
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Sundsvall, 852 31, Sweden
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Umeå, 901 85, Sweden
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Västerås, s-721 89, Sweden
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Basel, 4031, Switzerland
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Bangkok, 10400, Thailand
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Related Publications (11)
Patel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21.
PMID: 38904251DERIVEDKondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
PMID: 37366061DERIVEDShen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.
PMID: 34101002DERIVEDWang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
PMID: 33089502DERIVEDKristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.
PMID: 32720404DERIVEDDocherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.
PMID: 31849164DERIVEDDewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9.
PMID: 31813280DERIVEDShen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.
PMID: 29141857DERIVEDKristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.
PMID: 29018174DERIVEDKristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.
PMID: 28948656DERIVEDMcMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.
PMID: 27043774DERIVED
MeSH Terms
Interventions
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 2, 2009
Study Start
March 1, 2009
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 25, 2016
Results First Posted
November 25, 2016
Record last verified: 2016-10