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Article History

Received: 29 May 2025

Accepted: 28 October 2025

First Online: 19 November 2025

Declarations

:

: This study was conducted using fully anonymized administrative data from the NHD database of the Italian Ministry of Health and did not involve any direct experimentation or interaction with human subjects, nor the use of identifiable personal information. Therefore, according to Italian legislation, ethical review and approval were not required.Specifically, Decree Law No. 158/2012 (converted into Law No. 189/2012), together with the Ministerial Decree of February 8, 2013, defines the responsibilities of ethics committees in Italy as pertaining to clinical trials of medicinal products, studies involving medical devices, surgical or clinical procedures, or research on food products involving human subjects. As this study is based solely on anonymized administrative data and does not fall into any of these categories, it is exempt from ethical review.Moreover, the study complies with the General Authorization for the Processing of Personal Data for Scientific Research Purposes, issued by the Italian Data Protection Authority (Authorization No. 9/2014), which permits the use of fully anonymized data without requiring informed consent. Given the nature of the data and the study design, the requirement for informed consent was also waived in accordance with national legislation.This study was conducted in accordance with the ethical standards of institutional and national research governance and with the principles of the 1964 Declaration of Helsinki and its later amendments.

: Not applicable.

: The authors declare no competing interests.