Funding for this research was provided by:
Italian Ministry of Health (GR-2016-02361162)
Received: 16 December 2019
Accepted: 23 May 2020
First Online: 9 June 2020
Ethics approval and consent to participate
: The Tuscany Regional Ethics Committee of the University Hospital of Careggi, Florence has reviewed and approved the version 2.0 of the study protocol of 16 April 2018 (12773_SPE). The study will be conducted in accordance with the Declaration of Helsinki and the Data Protection Act. Trial personnel will obtain informed consent from each participant before inclusion. All individuals will be free to withdraw from the study at any time. Ethics Committee’s approval included the trial protocol, information sheet and consent form, questionnaires, interviews, any other written information that will be provided to the participants and any advertisements that will be used during the study. The trial is registered at the clinical trial registration (clinicaltrials.gov: NCT03962335, registered on 21 May 2019) in accordance with the International Committee of Medical Journal editors (ICMJE) requirements. Given the nature of the study, post-trial provisions are not required.
: Results from this study will be presented in publications and meetings but will not contain any identifying information. Consent for publication as well as sample storage for future research will be obtained from participants in the study.
: The Authors declare that they have no competing interests and the research is not being supported by any commercial organization.