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Article History

Received: 17 May 2024

Accepted: 25 July 2024

First Online: 5 August 2024

Declarations

:

: Favorable judgment for the execution of the study was obtained before data acquisition from the local institutional review board of the coordinating center Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy (Approval date: 24/04/2020; number 3375) and from the local institutional review board of each enrolled center (Policlinico San Marco, Gruppo Ospedaliero San Donato, Zingonia, Bergamo, Italy; Ospedale Infermi, Rimini, Italy; Ospedale Papa Giovanni XXIII, Bergamo, Italy; Ospedale Alessandro Manzoni, Lecco, Italy; Arcispedale Sant’Anna, Ferrara, Italy; Ospedale Santa Maria delle Stelle, Melzo, Italy; Istituto Sicureza Sociale, Repubblica di San Marino). The study was performed in accordance with the Declaration of Helsinki and in agreement with the Italian good clinical practice recommendations (D.M. Sanità del 15/07/97 e s.m.i.) and with the applied healthcare hospital protocols. CIn the presence of technical difficulties related to the emergency health context to obtain an informed consent from patients in that period of pandemic, informed consent was waived. For this reason and for the great public interest of the project, the research was conducted in the context of the authorizations guaranteed by Article 89 of the GDPR EU Regulation 2016/679, which guarantees the treatment for purposes of public interest, scientific or historical research or for statistical purposes of health data. Personal data were handled in compliance with the European Regulation on the Protection of Personal Data (GDPR), the Legislative Decree 196/2003 and subsequent amendments and additions, and any other Italian law applicable to the protection of personal data (henceforth referred to as the “applicable data protection law”).

: No individual person’s data in any form is reported in the manuscript.

: The authors declare no competing interests.