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Article History

Accepted: 25 March 2025

First Online: 13 April 2025

Declarations

:

: Open access funding provided by Università degli Studi di Verona within the CRUI-CARE Agreement.

: G.T. has served, over the last 3 years, on advisory boards/seminars funded by Sanofi, MSD, Eli Lilly, Sobi, Celgene, Daiichi Sankyo, Novo Nordisk, Gilead, and Amgen on topics not related to content of this paper; he is also a scientific coordinator of the academic spin-off “INSPIRE srl,” which has received funding from several pharmaceutical companies (Kiowa Kirin, Shionogi, Shire, Novo Nordisk, and Daiichi Sankyo) for conducting observational studies and additional consultancy services on topics not related to content of this paper. In addition, he is currently a consultant for Viatris in a legal case concerning an adverse reaction to sertraline. G.C. is a full-time employee of Bayer AG. A.B. is an employee of GSK and holds both stock and stock options with GSK. J.S.B. is an employee of TriNetX, LLC. T.A.H. is an employee at Takeda Pharmaceutical, United States. When the project started, M.S. was an employee at Daiichi Sankyo Inc. but currently, she is an employee at Bayer Inc. and receives stocks from the organization. However, the organization did not sponsor this manuscript, and the views expressed in this document do not represent the organization. A.Se. is an employee of the European Medicines Agency. A.B., G.N.N., S.S., M.T., E.v.P., and G.T. are Editorial Board members of Drug Safety, but were not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. The other authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the article apart from those disclosed.

: Not applicable. This study does not involve any human or animal subjects, or any sensitive information.

: Not applicable, as this study does not involve any human participants.

: Not applicable, as this study does not involve any individual data or images that would require consent for publication.

: Data sharing does not apply to this article as no datasets were generated or analyzed during the current study.

: Not applicable, as no custom code or software application was developed or used in this study.

: S.C.: writing—original draft, writing—review and editing, and visualization. A.B.: writing—review and editing. J.S.B.: writing—review and editing. G.C.: writing—review and editing. R.E.C.: writing—review and editing. T.A.H.: writing—review and editing. S.L.: writing—review and editing. J.C.M.: writing—review and editing. G.N.N.: writing—review and editing. A.P.: writing—review and editing. M.R.: writing—review and editing. M.S.: writing—review and editing. A.Se.: writing—review and editing. S.S.: writing—review and editing. A.Sp.: writing—review and editing. S.T.: writing—review and editing. M.T.: writing—review and editing. E.v.P.: writing—review and editing. G.T.: writing—original draft, writing—review and editing, supervision, and conceptualization. All authors read and approved the final version.