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Article History

Received: 26 December 2023

Accepted: 2 October 2024

First Online: 21 October 2024

Declarations

:

: The French Commission on Information Technology and Liberties (CNIL) approved the French national health data system (SNDS), including the EGB database used in this study; informed consent is waived for the use of these anonymized secondary data, as mentioned in the Social Security Code, Article L161–28 − 1. As per the decree no. 2016 − 1871 of December 26, the French National Institute for Health and Medical Research (INSERM) has a permanent right to access the EGB database. Thus, no additional approval from an ethical committee or a national commission for the protection of individual data was required. The research protocol of the current study is compliant with the internal control process set up by the Inserm SNDS Service Center, in conjunction with the establishment’s data protection delegate (DPO); Internal compliance approval was granted on 25/07/2022. Access to the EGB database was possible only through a secure connection to a specific server. Data access and management were conducted using the software SAS Enterprise Guide version 7.15 (Copyright © 2006–2010, SAS Institute Inc., Cary, NC, USA). Access to the SNDS database is granted to Inserm research units by French legislation (article R1461-13 of Code de la Santé Publique). Under this legal framework, studies approved by Inserm’s data committee using data solely from French medico-administrative databases (SNDS) do not require separate ethics committee authorization. The SNDS does not contain any data that is directly identified. The application of all measures to preserve data confidentiality, integrity, and traceability of access and other processing, as described by the law (article R1461-1 of Code de la Santé Publique), are guaranteed by Inserm.

: Not applicable.

: The authors declare no competing interests.

: Not applicable.