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Registration of the study with the European Union Clinical Trials Register (EudraCT) was not required. Before the study was conducted, the clinical investigation plan and any subsequent amendments were submitted to and approved by the relevant Ethics Committees: Comitato Etico Palermo 1, Azienda Ospedaliero Universitaria Policlinico \u201cPaolo Giaccone\u201d, Palermo, Italy, and the Comitato Etico Catania 1, Azienda Ospedaliero Universitaria Policlinico \u201cG. Rodolico-San Marco\u201d, Catania, Italy. Written informed consent was collected from all patients at enrollment. A progressive unique numerical code was assigned to each patient, and data relating to that patient was kept anonymized throughout the study. Project management, protocol and report medical writing, and monitoring study activities were carried out by the Contract Research Organization (CRO), UNIFARM Research Centre, Catania, Italy. 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