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Article History

Received: 26 July 2023

Accepted: 21 February 2024

First Online: 28 February 2024

Declarations

:

: The Tuscany Regional Ethics Committee of the Azienda Ospedaliera Universitaria (AOU)—Careggi, Florence, reviewed and approved the study protocol (n 21035_spe). The study will be conducted in accordance with the Declaration of Helsinki and the Data Protection Act. Ethics Committee approval included the study protocol, information sheet and consent form, questionnaires, interviews, any other written information that will be provided to participants, and any advertising that will be used during the study. The study is registered at the Clinical Trials Registry (ClinicalTrials.gov: NCT05941871, registered on 18/05/2023) in accordance with the requirements of the International Committee of Medical Journal editors (ICMJE). Due to the nature of the study, no post-trial arrangements are required.

: The results of this study will be presented in publications, meetings, and scientific conferences, but will not contain identifying information. Study participants will give their consent to the publication and preservation of samples for future research.

: The authors declare that they have no competing interests, and the research is not being supported by any commercial organization.