Ethics approval and consent to participate
The study was approved by the local ethics committee (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, study protocol code GIA-DAP-16–005) and registered at eudract.ema.europa.eu (EudraCT No. 2016-003614-27) and ClinicalTrials.gov (NCT 03313752). Informed, written consent was obtained from all participants.