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Authors
Yanover, Chen
Magen-Rimon, Ramit
Voss, Erica A.
Swerdel, Joel
Sheahan, Anna
Hall, Nathan
Park, Jimyung
Park, Rae Woong
Lee, Kwang Jae
Shin, Sung Jae
Seo, Seung In
Lee, Kyung-Joo
Falconer, Thomas
Haas, Leonard
Nagy, Paul
Bowring, Mary Grace
Cook, Michael
Miller, Steven
El-Hay, Tal
Bivas-Benita, Maytal
Akiva, Pinchas
Chowers, Yehuda
Weisshof, Roni
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Funding
Funding for this research was provided by:
Ministry of Health & Welfare, Republic of Korea (HR16C0001, HR16C0001, HR16C0001, HR16C0001)
National Heart, Lung, and Blood Institute (HL168842)
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Article History
Received: 10 September 2024
Accepted: 4 December 2024
First Online: 26 December 2024
Declarations
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: EAV, JS, AS, and NH are employees of Janssen Research and Development LLC and shareholders of Johnson & Johnson (J&J) stock; SM previously consulted for Surescripts and now consults for First Databank; YC is employee of CytoReason.
: The New England Institutional Review Board determined that studies conducted in CCAE, MDCR, MDCD, OPTUM-EHR, and OPTUM-CDM were exempt from study-specific Institutional Review Board review, as these studies do not qualify as human subject research. For use of IQVIA™’s FRANCE, GERMANY, AUSTRALIA, AMB-EMR, and PharMetrics+ , no patient permission was necessary because all patient data are deidentified for research purposes. Based on Ethical Guidelines for Epidemiological Research issued by the Japanese Ministry of Health, Labor and Welfare, ethics approval and informed consent were not applicable for use of JMDC. The use of AUSOM data in this study was approved by the Institutional Review Board of Ajou University Hospital (IRB number: AJOUIRB-MDB-2022–263) and the use of KDH data—by the Institutional Review Board of Kangdong Sacred Heart Hospital (IRB number: 2022–09-021); both committees waived the requirement for informed consent. IQVIA™ Scientific Review Committee approved the use of IMRD-UK data for this study (SRC Reference Number: 21SRC066). The research was approved by the Columbia University Institutional Review Board, as an OHDSI network study, and by the Johns Hopkins institutional review board.
