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Authors
Ly, Nelly F. https://orcid.org/0000-0002-7527-110X
Flach, Clare
Lysen, Thom S.
Markov, Emanuil
van Ballegooijen, Hanne
Rijnbeek, Peter
Duarte-Salles, Talita
Reyes, Carlen
John, Luis H.
Karimi, Leila
Reich, Christian
Salek, Sam
Layton, Deborah
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Funding
Funding for this research was provided by:
European Medicines Agency
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Article History
Accepted: 1 March 2023
First Online: 28 March 2023
Declarations
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: This study was funded by the EMA.
: This document expresses the opinion of the authors of this 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.
: Not applicable.
: Not applicable.
: This retrospective study using secondary data was conducted in accordance with the ethical standards of the institutional and national research committees and with the Declaration of Helsinki. The study protocol has been reviewed by the Institutional Review Boards of the respective databases. As this was a non-interventional observational study, there was no need for ethical approval in the Netherlands, UK, Belgium, Germany, and France. For SIDIAP (Spain), the scientific committee for SIDIAP studies and the local ethics committee evaluated the protocol before the study was carried out (#21/272-P).
: Informed consent was unnecessary as the study used only electronic health medical records, which had been de-identified prior to data access.
: Not applicable.
: NFL, CF, TL, EM, HvB, LK, CR and DL are employees of IQVIA. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
