Dinu, Monica
Angelino, Donato
Del Bo’, Cristian
Serafini, Mauro
Sofi, Francesco
Martini, Daniela http://orcid.org/0000-0001-8298-926X
Article History
Received: 25 April 2024
Accepted: 16 September 2024
First Online: 30 September 2024
Declarations
:
: The study protocol was reviewed and approved by the Ethics Committee of the University of Milan (n spe123.23, date 21/11/2023) and by the Tuscany Regional Ethics Committee of the Azienda Ospedaliera Universitaria (AOU) - Careggi, Florence (n 26392_spe, date 24/09/2024). 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: NCT06314932, registered on 13/03/2024) in accordance with the requirements of the International Committee of Medical Journal editors (ICMJE).
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: The authors declare that they have no competing interests, and the research is not being supported by any commercial organization.