Funding for this research was provided by:
Ministero della Salute (RF-2018-12365514)
Received: 25 February 2020
Accepted: 5 April 2020
First Online: 8 June 2020
Ethics approval and consent to participate
: The study has been approved by the ethical committees (Ecs) of the three main participating centres: EC of IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli (31/07/2019; no. 211/2019), EC of Area Vasta Emilia Nord (25/09/2019; no. 0025975/19), and EC of Pavia (02/09/2019, no. 20190075685). The research team will obtain oral and written informed consent to participate in the study from all participants before enrolment. All changes to this protocol will be sent for approval to the Ethical Committee of the IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli (Brescia, Italy) and to the Ecs of the other participating centres.
: Not applicable.
: The authors declare that they have no competing interests.