Higher dose tested to help people with rare lung disease live longer, stay out of hospital
NCT ID NCT04273945
Summary
This study is testing if a higher dose (75 mg) of the drug macitentan is better than the standard dose (10 mg) at delaying serious health problems or death in adults with pulmonary arterial hypertension (PAH), a rare and serious lung disease. About 935 participants will be randomly assigned to receive one of the two doses to see which one helps people live longer and avoid hospital stays. The main goal is to see if the higher dose can extend the time before a patient experiences a major health event like hospitalization for worsening PAH or death.
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Contacts and locations
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Locations
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AOU Di Modena Policlinico Di Modena
Modena, 41125, Italy
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ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
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Adana City Hospital
Adana, 01170, Turkey (Türkiye)
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Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
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Ahepa University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
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Akdeniz University Medical Faculty
Antalya, 07059, Turkey (Türkiye)
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Akershus Universitetssykehus
Nordbyhagen, 1478, Norway
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Alexandra General Hospital of Athens
Athens, 11528, Greece
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Allegheny General Hospital of Research
Pittsburgh, Pennsylvania, 15212, United States
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Altay Regional Cardiological Dispensary
Barnaul, 656055, Russia
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AnMed Health
Anderson, South Carolina, 29621, United States
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Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
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Ankara Etlik Speciality Hospital
Ankara, 06170, Turkey (Türkiye)
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Aphm - Hopital Nord
Marseille, 13915, France
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Arizona Pulmonary Specialists, Ltd
Scottsdale, Arizona, 85258, United States
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Asan Medical Center
Seoul, 05505, South Korea
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B.D. Mehta Mahavir Heart Institute
Surat, 395001, India
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Baylor College of Medicine (BCM) - Baylor Heart Clinic
Houston, Texas, 77030, United States
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Baylor Scott White - Plano
Plano, Texas, 75093, United States
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Beijing Anzhen Hospital
Beijing, 100029, China
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Beijing Chaoyang Hospital
Beijing, 100020, China
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Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16310, Turkey (Türkiye)
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CHRU de Lille Hopital Claude Huriez
Lille, France
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CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42277, France
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CHU de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
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CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
Cherkassy, 18000, Ukraine
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CNE' City Clinical Hospital #8' of Kharkiv City Council
Kharkiv, 61176, Ukraine
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Care Hospitals
Hyderbad, 500034, India
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Carmel Medical Center
Haifa, 34362, Israel
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Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
Nice, 06002, France
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Centro Cardiovascular Colombiano Clínica Santa María
Medellín, 681004, Colombia
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Centro Médico Dra. De Salvo
Caba, C1426ABP, Argentina
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Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
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Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80060-240, Brazil
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Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 454076, Russia
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Cho Ray Hospital
Ho Chi Minh City, 700000, Vietnam
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Cims Hospital
Ahmedabad, 381060, India
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Cleveland Clinic
Weston, Florida, 33331 3609, United States
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Clínica Imbanaco S.A.S.
Cali, 760042, Colombia
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Columbia University
New York, New York, 10032, United States
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Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
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Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
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Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez
Guadalajara, 44657, Mexico
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Cukurova University Medical Faculty
Adana, 01790, Turkey (Türkiye)
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Dokuz Eylul Universitesi Tip Fakültesi Hastanesi
Izmir, 35330, Turkey (Türkiye)
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Dr Kalla
Lenasia, 1820, South Africa
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Duke
Durham, North Carolina, 27710-4000, United States
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Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
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Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia
Brasília, 70840-901, Brazil
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Erasmus MC
Rotterdam, 3015 CN, Netherlands
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Fiona Stanley Hospital
Murdoch, 6150, Australia
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Flinders Medical Centre
Bedford Park, 5042, Australia
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Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
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Fondazione Toscana Gabriele Monasterio CNR
Pisa, 56124, Italy
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Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
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Fujita Health University Hospital
Toyoake, 470-1192, Japan
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Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
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Fundacion Cardiovascular de Colombia
Bucaramanga - Piedecuesta - Valle de Menzuli, 6810002, Colombia
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Fundacion Neumologica Colombiana
Bogotá, 1101131, Colombia
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GB Pant Institute of Post Graduate Medical Education & Research
New Delhi, 110002, India
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Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
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General University Hospital II.department of Internal Medicine-cardiology and angiology
Prague, 128 08, Czechia
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Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly
Budapest, 1096, Hungary
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Govindaswamy Kuppuswamy Naidu Memorial Hospital
Coimbatore, 64103, India
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Hacettepe University Medical Faculty
Ankara, 06230, Turkey (Türkiye)
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Hanoi Medical University Hospital
Hanoi, Vietnam
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HealthWorld Hospitals
Durgapur, 713216, India
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Hokkaido University Hospital
Sapporo, 060-8648, Japan
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Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, 94270, France
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Hopital Larrey CHU de Toulouse
Toulouse, France
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Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
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Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
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Hosp. Costa Del Sol
Málaga, 29603, Spain
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Hosp. Del Mar
Barcelona, 8003, Spain
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Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
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Hosp. Univ. La Paz
Madrid, 28046, Spain
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Hosp. Univ. Pta. de Hierro Majadahonda
Madrid, 28222, Spain
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Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-000, Brazil
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Hospital Italiano de Buenos Aires
Caba, 1199ABB, Argentina
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Hospital Pulau Pinang
George Town, 10990, Malaysia
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Hospital Serdang
Kajang, 43000, Malaysia
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Hospital Universidad del Norte
Soledad, 0000000, Colombia
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Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
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Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003, Brazil
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Hôpital Côte de Nacre
Caen, France
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Indiana University
Indianapolis, Indiana, 46202, United States
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Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, 50400, Malaysia
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Institute for Pulmonary Disease of Vojvodina
Kamenitz, 21204, Serbia
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Instituto Cardiovascular de Rosario
Rosario, S2000DSR, Argentina
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Instituto Medico de La Fundacion Estudios Clinicos
Rosario, 2000, Argentina
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Instituto Nacional de Cardiologia Dr. Ignacio Chavez
Mexico City, 14080, Mexico
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Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, 30441-070, Brazil
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Instituto de Cardiologia de Corrientes
Corrientes, W3400AMZ, Argentina
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Instituto de Medicina Integral Professor Fernando Figueira
Recife, 50070-902, Brazil
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Integris Baptist Office
Oklahoma City, Oklahoma, 73112, United States
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Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605008, India
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Jeffrey S. Sager, MD Medical Corporation
Santa Barbara, California, 93105, United States
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Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
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Juntendo University Hospital
Tokyo, 113-8431, Japan
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Kagoshima University Hospital
Kagoshima, 890 8520, Japan
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Kanazawa University Hospital
Kanazawa, 920 8641, Japan
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Kaplan Medical Center
Rehovot, 76100, Israel
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Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
Kartal Istanbul, 34865, Turkey (Türkiye)
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King Fahad Medical City
Riyadh, 59046, Saudi Arabia
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King Faisal Specialist Hospital & Research Center
Riyadh, 11564, Saudi Arabia
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Kobe University Hospital
Kobe, 650 0017, Japan
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Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, 31 202, Poland
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Kure Kyosai Hospital
Hiroshima, 737-8505, Japan
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Kurume University Hospital
Kurume, 830-0011, Japan
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Kyoto University Hospital
Kyoto, 606 8507, Japan
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Kyushu University Hospital
Fukuoka, 812 8582, Japan
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LKH-Univ. Klinikum Graz
Graz, 8036, Austria
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Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
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Lindner Clinical Trial Center/Christ Hospital
Cincinnati, Ohio, 45219, United States
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Louisiana State University
New Orleans, Louisiana, 70112 7021, United States
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502-2006, United States
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MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
Dnipro, 49070, Ukraine
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Mackay Memorial Hospital
Taipei, 10449, Taiwan
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Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, 50020, Thailand
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Marmara University Medical Faculty
Istanbul, 34899, Turkey (Türkiye)
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Mayo Clinic
Phoenix, Arizona, 85054, United States
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Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medical University Vienna
Vienna, 1090, Austria
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Medizinische Hochschule Hannover
Hanover, 30625, Germany
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Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU
München, 81377, Germany
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Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
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Milpark Hospital
Johannesburg, South Africa
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Minsk Regional Clinical Hospital
Minsk, 220143, Belarus
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Moscow City Clinical Hospital No.51
Moscow, 121309, Russia
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Mount Sinai
New York, New York, 10029, United States
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Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
Sofia, 1309, Bulgaria
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Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
Ternopil, 46002, Ukraine
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NHL Medical College (SVP Hospital IMSR)
Ahmedabad, 380006, India
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Nagasaki University Hospital
Nagasaki, 852-8501, Japan
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Nagoya City University Hospital
Nagoya, 467 8602, Japan
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Nagoya University Hospital
Nagoya, 466 8560, Japan
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Narayana Hrudayalaya Limited
Bangalore, 560099, India
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Narodny ustav srdcovych a cievnych chorob
Bratislava, 833 48, Slovakia
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National Cerebral and Cardiovascular Center
Suita-Shi, 564-8565, Japan
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National Cheng Kung University Hospital
Tainan, 704, Taiwan
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National Heart Centre (NHC) Singapore
Singapore, 169609, Singapore
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National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
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National Jewish Health
Denver, Colorado, 80206, United States
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National Medical Research Center of Cardiology of MoH of Russian Federation
Moscow, 121552, Russia
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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National University Heart Centre, Singapore
Singapore, 119228, Singapore
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National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
Saint Petersburg, 197341, Russia
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Niigata University Medical And Dental Hospital
Niigata, 951 8520, Japan
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Northside Hospital
Atlanta, Georgia, 30342, United States
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Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
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Okayama University Hospital
Okayama, 700 8558, Japan
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Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
México, 52787, Mexico
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Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
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Oregon Health And Science University
Portland, Oregon, 97239-3011, United States
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Oregon Pulmonary Clinic
Portland, Oregon, 97225-6652, United States
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Oslo University Hospital
Oslo, 372, Norway
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Ospedale San Francesco
Nuoro, 08100, Italy
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Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20160, Turkey (Türkiye)
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Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, 02 507, Poland
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Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs, 7624, Hungary
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Peking Union Medical College Hospital
Beijing, 100730, China
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Phramongkutklao Hospital and Medical College
Bangkok, 10400, Thailand
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Piedmont Healthcare
Atlanta, Georgia, 30309, United States
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Policlinico Gemelli Universita Cattolica
Roma, 00168, Italy
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Rabindranath Tagore International Institute of Cardiac Sciences
Kolkata, 700099, India
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Radboud Umcn
Nijmegen, 6525 GA, Netherlands
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Ramathibodi Hospital Mahidol University
Bangkok, 10400, Thailand
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Renji Hospital
Shanghai, 201112, China
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Reno Heart Institute
Reno, Nevada, 89511, United States
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Renova Century Hospitals
Hyderabad, 500034, India
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Royal Free Hospital
London, NW3 2QG, United Kingdom
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Royal Hobart Hospital
Hobart, 7000, Australia
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Royal Prince Alfred Hospital
Camperdown, 2050, Australia
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Ruhr Universitat Bochum Diabeteszentrum
Bad Oeynhausen, 32545, Germany
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SBU Izmir Tepecik Egitim Ve Arastirma Hastanesi
Izmir, 35020, Turkey (Türkiye)
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SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, 02000, Ukraine
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SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, 40 635, Poland
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SRM Medical College Hospital & Research Centre
Chengalpetu, 603203, India
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Sahlgrenska Universitetsjukhuset
Gothenburg, 413 45, Sweden
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Saint Louis University Academic Pavillion
St Louis, Missouri, 63110, United States
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Samara Regional Clinical Cardiological Dispensary
Samara, 443070, Russia
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Samsung Medical Center
Seoul, 06351, South Korea
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San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, 78229-3771, United States
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Sanatorio Guemes
C.a.b.a., C1180AAX, Argentina
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Sanatorio Ramon Cereijo
Caba, C1048AAN, Argentina
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Sanatorio de la Trinidad Mitre
Buenos Aires, C1039AAO, Argentina
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Sapporo Medical University Hospital
Sapporo, 060 8543, Japan
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Sarawak Heart Center
Kota Samarahan, 94300, Malaysia
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Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, 650002, Russia
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Scripps Memorial Hospital
La Jolla, California, 92037, United States
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Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909, Brazil
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Semmelweis Egyetem,Pulmonológiai Klinika
Budapest, 1083, Hungary
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Seoul National University Hospital
Seoul, 3080, South Korea
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Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
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Shaare Zedek Medical Center
Jerusalem, 91031, Israel
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Shanghai Pulmonary Hospital
Shanghai, 200433, China
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Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, S10 2RX, United Kingdom
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Shengjing Hospital Of China Medical University
Shenyang, 110004, China
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Shinshu University Hospital
Matsumoto, 390 8621, Japan
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Sir Ganga Ram Hospital
New Delhi, 110060, India
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Siriraj Hospital Mahidol University
Bangkok, 10700, Thailand
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Siyami Ersek Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
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Skanes universitetssjukhus
Lund, 221 85, Sweden
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Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron
Campina Grande do Sul, 83430-000, Brazil
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Songklanagarind hospital
Songkhla, 90110, Thailand
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Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
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St Marianna University Hospital
Kanagawa, 216 8511, Japan
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St Vincent's hospital
Darlinghurst, 2010, Australia
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St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
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St. Joseph's Health Centre
Hamilton, Ontario, L8N 4A6, Canada
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St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260, United States
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State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
Kazan', 420101, Russia
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State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
Tyumen, 625032, Russia
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State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, 03680, Ukraine
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Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
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Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
Szeged, 6720, Hungary
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Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, 85-168, Poland
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Taipei Veterans General Hospital
Taipei, 112, Taiwan
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Tam Anh Hospital
Ho Chi Minh City, 700000, Vietnam
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Tam Duc Heart Hospital
Ho Chi Minh City, 700000, Vietnam
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The Chaim Sheba Medical Center
Tel Litwinsky, 5265601, Israel
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The Eastern Slovakia Institute of Cardiovascular Diseases
Košice, 040 11, Slovakia
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
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The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
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The General Hospital of Northern Theater Command
Shenyang, 110000, China
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The Oregon Clinic
Portland, Oregon, 97220-9442, United States
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The Prince Charles Hospital
Chermside, 4032, Australia
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The Republican Scientific-Practical Center ''Cardiology''
Minsk, 220036, Belarus
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The Robert Larner, M.D. College of Medicine at The University of Vermont
Burlington, Vermont, 05405, United States
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The Second Xiangya Hospital of Central South Hospital
Changsha, 410011, China
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The University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
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Tianjin Medical University General Hospital
Tianjin, 300052, China
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Troy Beaumont
Troy, Michigan, 53215, United States
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ULB Hôpital Erasme
Brussels, 1070, Belgium
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USC Keck
Los Angeles, California, 90033, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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UZ Leuven
Leuven, 3000, Belgium
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Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, 3004 561, Portugal
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Uls Santa Maria - Hosp. Pulido Valente
Lisbon, 1769-001, Portugal
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Uls Sao Jose - Hosp. Santa Marta
Lisbon, 1169-024, Portugal
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Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
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Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
Monterrey, 64718, Mexico
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Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100, Brazil
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Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020, Brazil
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Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
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University Clinical Center of Serbia
Belgrade, 11000, Serbia
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University Health Network - Toronto General Hospital
Toronto, Ontario, M5G2C4, Canada
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University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
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University Hospital Of Larissa
Larissa, 41334, Greece
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University Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
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University Medical Center Ho Chi Minh city
Ho Chi Minh City, 700000, Vietnam
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University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, 1750, Bulgaria
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University Of Iowa - Hospitals & Clinics
Iowa City, Iowa, 52242, United States
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University of Michigan
Ann Arbor, Michigan, 48109-5000, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198-2265, United States
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University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104-5545, United States
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University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
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Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, 70 111, Poland
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Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
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Uniwersyteckie Centrum Kliniczne
Gdansk, 80214, Poland
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VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
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Volgograd Regional Clinical Cardiology Center
Volgograd, 400008, Russia
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Washington University School Of Medicine
St Louis, Missouri, 63110-1032, United States
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West China Hospital Sichuan University
Chengdu, 610041, China
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Westmead Hospital
Westmead, 2145, Australia
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Winthrop University Hospital
Mineola, New York, 11501, United States
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Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy
Wroclaw, 51 124, Poland
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Yitzhak Shamir Medical Center
Ẕerifin, 70300, Israel
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Ynova Pesquisa Clinica
Florianópolis, 88020-210, Brazil
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Zhongshan Hospital Fudan University
Shanghai, China
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Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
Aarhus, 8200, Denmark
Conditions
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