Arinze, Johnmary T. http://orcid.org/0000-0002-4981-6823
de Ridder, Maria A. J.
Vojinovic, Dina
van Ballegooijen, Hanne
Markov, Emanuil
Duarte-Salles, Talita
Rijnbeek, Peter
Verhamme, Katia M. C.
Funding for this research was provided by:
European Medicines Agency
Article History
Accepted: 18 September 2023
First Online: 31 October 2023
Declarations
:
: This study was funded by the European Medicines Agency (EMA).
: The authors, Johnmary T. Arinze, Maria A.J. de Ridder, Dina Vojinovic, Hanne van Ballegooijen, Emanuil Marko, Talita Duarte-Salles, Peter Rijnbeek, and Katia M. C. Verhamme, declare no conflicts of interest directly relevant to the content of this article. This document expresses the opinion of the authors of the paper, and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.
: The study protocol was reviewed by the institutional review boards (IRBs) of the respective databases. Given the non-interventional and observational nature of the study, ethical approval was not required for LPD Belgium, DA Germany, and LPD France. Ethical approval was granted for this study by the Scientific Review Committee (21SRC063) of IMRD (UK), the IPCI Review Board (Registration no. 8/2021) of IPCI Netherlands, and the Ethical Committee for Investigation of Medications (Code IEC: 21/272-P) of SIDIAP Spain.
: Informed consent was unnecessary as the study used only electronic health medical records, which had been de-identified prior to data access.
: Not applicable.
: Not applicable.
: Not applicable.
: The authors collectively take responsibility for all aspects of the work, ensuring its accuracy and integrity, as well as participating in manuscript revisions and approving the final version.