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Article History

Received: 17 April 2024

Accepted: 21 August 2024

First Online: 13 September 2024

Declarations

:

: The study protocol (version n.01, 7 August 2023) was approved by the Ethics Committee of the Region Liguria (n. 678/2022, 15 November 2023) and was registered in the Clinical Trials.gov database (identification number: NCT06224556). Any amendments in the study protocol will be submitted to the local ethics committee and communicated to the involved partners and GPs through official email communication. The consent form is signed after the anonymized randomization process, as described in the 2.1 paragraph. Data will be collected and managed according to Good Clinical Practice (D.Lgs. 211/2003) and to the current legislation on the management of personal data (Regulation (EU) 2016/679 and D.Lgs. 196/2003 as modified by D.Lgs. 101/2018). To ensure the confidentiality of collected data, each participant will be assigned an anonymized code, and their identification will be allowed only to the GP and the principal investigator. Data will be managed centrally by the coordinator center (Galliera Hospital, Genoa, Italy) as the only center responsible for processing and storing personal data. All data will be collected in a digital platform hosted on the hospital’s servers and available on its web domain. The coordinating center will monitor the data entry process.

: Not applicable.

: The authors declare no competing interests.