Conflict of interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.

Ethical approval

The protocol and the informed consent form were approved by the Local Committee for Clinical Ethics of Azienda USL Tuscany Nord-west (Prot. no. 40—26/09/2019). The study will be conducted in accordance with the standards as laid down in the in the 1964 Declaration of Helsinki and its later amendments and in compliance with the European Union's Good Clinical Practice Guidelines.

Informed consent

Informed consent will be obtained from all individual participants included in the study.

Consent to publish

In accordance with the nature of the data presented, publication consent is not required as it does not involve identifiable or sensitive information. Therefore, no consent for publication is necessary for the data presented in this paper.