New hope for AML patients? quizartinib trial targets Tough-to-Treat leukemia
NCT ID NCT06578247
First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This Phase 3 trial is testing whether adding the drug quizartinib to standard chemotherapy helps adults with newly diagnosed acute myeloid leukemia (AML) that lacks a specific genetic mutation (FLT3-ITD). About 700 participants will receive either quizartinib or a placebo alongside chemo, followed by maintenance therapy. The main goal is to see if the drug extends overall survival.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Quizartinib (a targeted cancer drug taken as a pill)
- What this could lead to
- If successful, this could provide a new treatment option for people with a common type of AML, potentially improving survival and delaying relapse.
- What could go wrong
- This is a large Phase 3 trial, but quizartinib has not yet been proven effective in FLT3-ITD negative AML. Side effects from the drug or added chemotherapy are possible, and the benefit over standard care remains uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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'Shathd' Ead Sofia
Sofia, 1797, Bulgaria
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AZ DELTA
Roeselare, 8800, Belgium
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Affiliated Hospital of Nantong University
Nantong, 226001, China
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Ajou University Hospital
Suwon, 16499, South Korea
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Akademiska Sjukhuset
Uppsala, 75185, Sweden
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Akita University Hospital
Akita, 010-8543, Japan
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Aomori Prefetural Central Hospital
Aomori, 030-8553, Japan
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Asan Medical Center
Seoul, 5505, South Korea
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Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
Varese, 21100, Italy
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Augusta University
Augusta, Georgia, 30912, United States
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Az Sint-Jan
Bruges, 8000, Belgium
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Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 133, Italy
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Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
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Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
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Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
Bari, 70124, Italy
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Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino
Torino, 10126, Italy
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Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Brescia, 25100, Italy
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Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, 20162, Italy
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Box Hill Hospital
Box Hill, 3128, Australia
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CHU Nice - Hôpital de l'Archet 1
Nice, 06200, France
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Centre Hospitalier Lyon Sud
Pierre BĂŠnite, 69495, France
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Centre Hospitalier de Versailles
Le Chesnay, 78150, France
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Centre Léon Bérard
Lyon, 69008, France
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Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
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Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
Campinas, 13083-878, Brazil
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Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina
Florianópolis, Brazil
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Cetus Hospital Dia Oncologia
Belo Horizonte, Brazil
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Chang Gung Memorial Hospital
Taoyuan County, 00333, Taiwan
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Charité Campus Virchow-Klinikum
Berlin, Germany
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Chiba Aoba Municipal Hospital
Chiba, 260-0852, Japan
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China Medical University Hospital
Taichung, 404327, Taiwan
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Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
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Chu Amiens - Hopital Sud
Salouël, 80480, France
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Chu Angers - Hăpital Hătel Dieu
Angers, 49033, France
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Chu Rennes - Hopital Pontchaillou
Rennes, 35000, France
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Chu de Bordeaux - Hăpital Haut-Lăvăque
Pessac, 33604, France
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Chu de Caen
Caen, 14033, France
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Chu de Grenoble - Hospital Albert Michallon
La Tronche, 38700, France
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Chu de Liage
Liège, 4000, Belgium
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Chu de Nantes - Hotel Dieu
Nantes, 44093, France
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Chugoku Central Hospital
Fukuyama, Japan
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Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
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City of Hope Phoenix
Goodyear, Arizona, 85338, United States
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Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
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Clinica Universidad de Navarra
Madrid, 28027, Spain
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Clinical Hospital Centar Zagreb
Zagreb, 10000, Croatia
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Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
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Clinical Hospital Dubrava
Zagreb, 10000, Croatia
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Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Complejo Hospitalario Universitario de Albacete
Albacete, 02006, Spain
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Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
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Concord Repatriation General Hospital
Concord, 2139, Australia
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Curie Oncology Pte Ltd
Singapore, 329563, Singapore
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Daegu Catholic University Medical Center
Daegu, 42472, South Korea
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David Geffen School of Medicine
Los Angeles, California, 90095, United States
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Debreceni Egyetem
Debrecen, 4032, Hungary
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Duke Cancer Institute - Sarcoma Research
Durham, North Carolina, 27710, United States
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Ehime Prefectural Central Hospital
Matsuyama, Japan
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Fakultni Nemocnice Brno
Brno, 625 00, Czechia
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Fakultni Nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
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Fakultni Nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
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Fakultni Nemocnice Ostrava
Poruba, 708 52, Czechia
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Fakultni Nemocnice Plzen
Pilsen, 304 60, Czechia
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Fiona Stanley Hospital
Murdoch, 6150, Australia
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Flinders Medical Centre (Fmc)
Bedford Park, 5042, Australia
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Flinders Medical Centre (Fmc)
Bedford Park, Australia
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Florida Hospital Cancer Institute - Kissimmee
Kissimmee, Florida, 34741, United States
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Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 168, Italy
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Fundacao Doutor Amaral Carvalho
Jaú, 17210-120, Brazil
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Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto, 15090-000, Brazil
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Gachon University Gil Medical Center
Incheon, 21565, South Korea
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Gifu Municipal Hospital
Gifu, Japan
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Guangdong Provincial People'S Hospital
Guangzhou, 510080, China
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Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024, Hungary
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HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, 74680160, Brazil
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HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, 60430-370, Brazil
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Hamamatsu University School of Medicine, University Hospital
Hamamatsu, 431-3192, Japan
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Hammersmith Hospital
London, W12 0HS, United Kingdom
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Hanusch Krankenhaus Der Wgkk Wien
Vienna, 1140, Austria
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Haukeland Universitetssykehus
Bergen, N-5021, Norway
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Henan Cancer Hospital
Zhengzhou, 450008, China
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Hokkaido University Hospital
Sapporo, 060-8648, Japan
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Hopital Claude Huriez - Chru Lille
Lille, 59037, France
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Hopital de La Conception - Aphm
Marseille, 13005, France
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Hospital Beneficencia Portuguesa da Sao Paulo
São Paulo, 01323-001, Brazil
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Hospital Clinico Universitario de Salamanca
Salamanca, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, 81520-060, Brazil
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Hospital General Universitario Doctor Balmis
Alicante, 03010, Spain
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Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
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Hospital Nove de Julho
São Paulo, 01409902, Brazil
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Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
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Hospital Saint-Louis
Paris, 75475, France
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Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
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Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
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Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
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Hospital Universitari Vall D'Hebron
Barcelona, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario De Burgos
Burgos, Spain
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Hospital Universitario Dr. Peset
Valencia, 46017, Spain
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario Marques de Valdecilla
Santander, 39012, Spain
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Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28220, Spain
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Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
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Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41010, Spain
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Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas, Spain
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Hospital de Clínicas de Passo Fundo
Passo Fundo, 99010-260, Brazil
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Hospital de Clănicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
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Hospital de La Santa Creu I Sant Pau
Barcelona, 8025, Spain
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
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INCA - Instituto Nacional de Cancer
Rio de Janeiro, Brazil
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Ico Badalona - Hospital Universitari Germans Trias I Pujol
Badalona, Spain
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Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
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Inselspital - Universitaetsspital Bern
Bern, 3010, Switzerland
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Institut Gustave Roussy
Villejuif, France
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Institut Jules Bordet
Anderlecht, 1070, Belgium
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Institut Universitaire Du Cancer de Toulouse- Iuct-O
Toulouse, 31059, France
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Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, 67200, France
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Institut de Cancărologie de Strasbourg Europe - Icans
Strasbourg, 67200, France
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Institute of Hematology and Hospital of Blood Disease
Tianjin, 300020, China
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Instituto Portugues De Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
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Institutul Clinic Fundeni
Bucharest, 022328, Romania
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Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
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Instytut Hematologii I Transfuzjologii
Warsaw, 02-776, Poland
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Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
Meldola, 47014, Italy
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Irccs Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013, Italy
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Istituto Clinico Humanitas
Rozzano, 20089, Italy
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Jeonbuk National University Hospital
Jeonju, 54907, South Korea
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Kanazawa University Hospital
Kanazawa, 920-8641, Japan
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
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King'S College Hospital
London, SE5 9NU, United Kingdom
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Klinika Hematoonkologii I Transplantacji Szpiku
Lublin, 20-081, Poland
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Klinikum Aschaffenburg-Alzenau
Alzenau in Unterfranken, 63755, Germany
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Korea University Guro Hospital
Seoul, 08308, South Korea
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Krh Klinikum Siloah
Hanover, 30459, Germany
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Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
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Kyushu University Hospital
Fukuoka, 812-8582, Japan
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LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
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Liverpool Hospital
Liverpool, 2170, Australia
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London Health Sciences Centre
London, N6A 5W9, Canada
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Luzerner Kantonsspital - Luzern
Lazern 16, Switzerland
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Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
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Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
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Mayo Clinic Hospital
Jacksonville, Florida, 32224, United States
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McGill University - Dept. Oncology Clinical Research Program
Montreal, Canada
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Md Anderson Cancer Centre
Madrid, 28033, Spain
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center - Main
Long Island City, New York, 11101, United States
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Memorial Sloan Kettering Cancer Center - Main
New York, New York, 10065, United States
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Military Medical Academy
Belgrade, 11000, Serbia
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Military Medical Academy - Mhat - Sofia
Sofia, 1606, Bulgaria
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
-
Nagoya University Hospital
Nagoya, 466-8560, Japan
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National Cheng Kung University Hospitalx
Tainan, 70403, Taiwan
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National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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National University Hospital
Singapore, 119228, Singapore
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Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
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Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121, United States
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Ohio Health Research Institute
Columbus, Ohio, 43214, United States
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Ordensklinikum Linz Gmbh - Elisabethinen
Linz, 4020, Austria
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Oregon Health & Science University (Ohsu)
Portland, Oregon, 97239, United States
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Osaka Red Cross Hospital
Osakar, 543-8555, Japan
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Oslo University Hospital Rikshospitalet Clinical Research Unit
Oslo, Norway
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Ospedale Maggiore Di Novara
Novara, Italy
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Ospedale Mauriziano Umberto I
Torino, 10128, Italy
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Ospedale San Raffaele
Milan, 20132, Italy
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Peggy & Charles Stephenson Oklahoma Cancer Ctr
Oklahoma City, Oklahoma, 73104, United States
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Peking Union Medical College Hospital
Beijing, 100730, China
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Peking University First Hospital
Beijing, 100034, China
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Peking University Third Hospital
Beijing, 100191, China
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Princess Alexandra Hospital
Woolloongabba, 4102, Australia
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Princess Margaret Cancer Center
Toronto, M5G 2M9, Canada
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Pusan National University Hospital
Busan, South Korea
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Qilu Hospital of Shandong University
Jinan, 250012, China
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Queen Elizabeth Hospital
Birmingham, United Kingdom
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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Robert H Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, 60611, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
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Royal Adelaide Hospital
Adelaide, 5000, Australia
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Sahlgrenska Universitetssjukhuset
Gasteborg, 41345, Sweden
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Saiseikai Maebashi Hospital
Maebashi, Japan
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Samsung Medical Center
Seoul, 06351, South Korea
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Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074, Brazil
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Sapporo Hokuyu Hospital
Sapporo, Japan
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Saskatoon Cancer Centre
Saskatoon, S7N 4H4, Canada
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Semmelweis Egyetem
Budapest, 1088, Hungary
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Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
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Seoul National University Hospital
Seoul, 110-744, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
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Shanghai Tongren Hospital
Shanghai, 200050, China
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Shengjing Hospital of China Medical University
Shengyang, 110004, China
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Shenzhen Second People'S Hospital
Shenzhen, 518029, China
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Sir Charles Gairdner Hospital
Perth, 6009, Australia
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Skă Nes Universitetssjukhus, Lund
Lund, 22185, Sweden
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South Austin Medical Center
Austin, Texas, 78745, United States
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Spitalul Clinic Colentina
Bucharest, 020125, Romania
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Spitalul Clinic Coltea
Bucharest, 030171, Romania
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Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
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St Vincent'S Hospital Melbourne
Darlinghurst, 2010, Australia
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Staedtisches Klinikum Braunschweig Ggmbh
Braunschweig, 38114, Germany
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Stanford University School of Medicine- Parent
Stanford, California, 94305, United States
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Sun Yat-Sen University, Cancer Center
Guangzhou, 510060/510700, China
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Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
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Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
São Paulo, Brazil
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
-
Tampa General Hospital
Tampa, Florida, 33606, United States
-
Tenri Hospital
Tenri, 632-8552, Japan
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Tesshokai Kameda General Hospital
Kamogawa-shi, 296-8602, Japan
-
The Affiliated Hospital of Qingdao University
Qingdao, 266071, China
-
The Alfred Hospital
Melbourne, 3004, Australia
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The Catholic University of Korea, Seoul St. Mary'S Hospital
Seoul, 06591, South Korea
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The Chinese University of Hong Kong (Cuhk)
Shatin, 00000, Hong Kong
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
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The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
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The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325015, China
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The First Affiliated Hospital of Xiâan Jiaotong University
Xi'an, 710061, China
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The First Hospital of Jilin University
Changchun, 130021, China
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The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
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The Ottawa Hospital - General Campus
Ottawa, K1H 8L6, Canada
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The Second Hospital of Hebei Medicical University
Shijiazhuang, China
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The Second Xiangya Hospital of Central South University
Changsha, 410011, China
-
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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The University of Hong Kong
Hong Kong, Hong Kong
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The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
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Thomas Jefferson Univ Hosp
Haddonfield, New Jersey, 08033, United States
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Tianjin Medical University General Hospital
Tianjin, 300052, China
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Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, 113-8677, Japan
-
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
-
Townsville University Hospital
Douglas, 4814, Australia
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Tristar Bone Marrow Transplant
Nashville, Tennessee, 37203, United States
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Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
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Ulsan University Hospital
Ulsan, 44033, South Korea
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Umhat 'Dr. Georgi Stranski', Ead
Pleven, 5800, Bulgaria
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Umhat 'Sv. Georgi', Ead
Plovdiv, 4002, Bulgaria
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Umhat Prof. Dr. Stoyan Kirkovich Ad
Stara Zagora, 6000, Bulgaria
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Umhat Âsv. Ivan Rilskiâ, Ead
Sofia, 1431, Bulgaria
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Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
Botucatu, 18618-686, Brazil
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Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, 01307, Germany
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Universitaetsklinikum Essen
Essen, 45147, Germany
-
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
-
Universitaetsklinikum Heidelberg
Heidelberg, Germany
-
Universitaetsklinikum Muenster
Münster, Germany
-
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
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University Clinical Center Nis
Niš, 18000, Serbia
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University Clinical Center of Serbia
Belgrade, 11000, Serbia
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University Hospital of North Norway
Tromsø, 9019, Norway
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University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
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University of California Davis Health System
Sacramento, California, 95817, United States
-
University of Cincinnati
Cincinnati, Ohio, 45219, United States
-
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612, United States
-
University of Kentucky
Lexington, Kentucky, 40504, United States
-
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109, United States
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University of Minnesota Medical School - Twin Cities Campus
Minneapolis, Minnesota, 55455, United States
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University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol
Leipzig, 4103, Germany
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Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Upstate University Hospital
Syracuse, New York, 13210, United States
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Ustav Hematologie A Krevni Transfuze
Prague, 12800, Czechia
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Uva Health System
Charlottesville, Virginia, 22908, United States
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Uz Leuven
Leuven, 3000, Belgium
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Virginia Commonwealth University (Vcu) Massey Cancer Center
Richmond, Virginia, 23229, United States
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Washington University
St Louis, Missouri, 63110, United States
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Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
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Wuxi People'S Hospital
Wuxi, 214023, China
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Xiangya Hospital, Central South University
Changsha, 410008, China
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Yale University
New Haven, Connecticut, 06510, United States
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Yantai Yuhuangding Hospital
Yantai, 264000, China
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Yeungnam University Hospital
Daegu, 42415, South Korea
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ZNA
Antwerp, 2060, Belgium
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Zhong Da Hospital, Southeast University
Nanjing, 210009, China
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