Ethics approval and consent to participate
The study was carried out in accordance with the Declaration of Helsinki.The local Ethical Committee of Messina approved the study protocol (ID 01–2020, on 04/27/2020), in accordance with the Helsinki declarations. The study was registered on ClinicalTrials.gov (ID: NCT05488028).Patients had given their informed consent to treatment and were informed that their data would be used for statistical analyses related to this study.