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Article History

Received: 30 June 2025

Accepted: 9 December 2025

First Online: 13 January 2026

Declarations

:

: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The information provided in this article does not represent the opinion of the French National Agency for the Safety of Medicines and Health Products (ANSM).

: The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was not required because the analysis was based on data from the French National Pharmacovigilance Database, which contains anonymised spontaneous reports collected within the French pharmacovigilance system (coordinated by the French National Agency for the Safety of Medicines and Health Products [ Agence Nationale de Sécurité du Médicament et des Produits de Santé ]).

: Not applicable. Patient consent was not required since the study used anonymised secondary data that could not be used to identify individuals.

: Not applicable. The study did not include any identifiable individual data.

: Data sharing is not applicable to this study because the datasets used were derived from the French National Pharmacovigilance Database. These anonymised datasets are protected by confidentiality agreements and the regulations of the French Data Protection Commission ( Commission Nationale de l’Informatique et des Libertés ) and cannot be made publicly available.

: The code will be made available upon reasonable request to the corresponding author.

: PEP, SML and SL contributed to the conception/design of the work; the acquisition, analysis and interpretation of the data; drafting the work and revising it critically for important intellectual content. JM, VG, PS, and SP critically revised the manuscript for important intellectual content. All authors (PEP, SML, SL, JM, VG, PS, and SP) read and approved the final version of the manuscript.