Ethical Considerations
The Ethical Review Board of Azienda Ospedaliero Universitaria “Policlinico-V. Emanuele,” Università di Catania, Italy, reviewed and approved the study (approval reference number: 215/2017/PO). All participants provided written informed consent prior to participation in the study. The study has been registered at ClinicalTrial.gov (trial registration ID: NCT03569748). Study data are deidentified, and participants did not receive compensation.