Ethics statement
The studies involving humans were approved by the local Ethical Committee with Authorization Number AOU 0010923/19 on 12/04/2019 and AIFA Authorization Number AIFA/SC/P/33830 on 25/03/2019. EudraCT Number 2018-003458-26. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.