Ethics approval and consent to participate
n.18
The clinical study protocol has been approved by the Regulatory Authorities AIFA/ISS (Italy) (AIFA/SC/P/34930-27/05/2018, amendment AIFA/SC/P/4261—15/01/2020) and by the local Ethics Committee (n. 207-19/07/2018, amendment n.18 -16/01/2020). All patients wrote an informed consent to participate in the study.