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Article History

Received: 12 June 2025

Accepted: 17 July 2025

First Online: 25 July 2025

Declarations

:

: Dora Intagliata, Massimiliano Priolo, and Paola Molinari declare that they have no conflicts of interest to disclose.

: This was a non-interventional, non-pharmacological observational study conducted in a private clinical setting, without the use of drugs, medical devices, or invasive or diagnostic procedures beyond routine care. Under Italian law, only pharmacological observational studies or studies with medical devices are subject to ethics committee approval and mandatory registration with the AIFA (Italian Medicines Agency) via the Registro Studi Osservazionali (RSO). This is clearly specified in the Ministerial Decree of November 30, 2021 (Italian Ministry of Health) and in AIFA Determination No. 425/2024 – Guidelines on Observational Studies (published on March 7, 2024). All participants have given written informed consent before inclusion in the study, in accordance with the principles of the Declaration of Helsinki.