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Article History

Accepted: 7 March 2024

First Online: 9 April 2024

Declarations

:

: No funding was received for the preparation of this article.

: Karin Hedenmalm, Kate Browne, Robert Flynn, Loris Piccolo, Aniello Santoro, Cosimo Zaccaria and Xavier Kurz are employees of the European Medicines Agency. María Gordillo-Marañón was an employee of the European Medicines Agency during the conceptual design, drafting and review of the manuscript. Gianmario Candore was not an employee of Bayer AG during the conceptual design, drafting and review of the manuscript. Bayer AG did not contribute to this article.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: All authors meet ICMJE criteria, they have all contributed to the development of the study, as well as to the writing and approval of the manuscript.

: The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated.