Ethics approval and consent to participate
DEL
The protocol was approved by the ethics committee of the ‘Università Cattolica del Sacro Cuore’ (Ref. 50053/19) and is registered at ClinicalTrials.gov (ID: NCT05103124). The informed consent was carried out in line with the Declaration of Helsinki and was obtained from all subjects involved in the study. Written informed consent approved by the ethics committee (Ref. 50053/19) has been obtained from the patients to publish this paper.