Goker, Funda http://orcid.org/0000-0002-2354-361X
Donati, Girolamo
Gallo, Francesco
Sparaco, Antonella
Rania, Vito
Busa, Alberto
Grecchi, Francesco
Grecchi, Emma
Colapinto, Gianluca
Del Fabbro, Massimo http://orcid.org/0000-0001-7144-0984
Article History
Received: 30 August 2023
Accepted: 18 March 2024
First Online: 25 March 2024
Declarations
:
: The study protocol was approved by the Ethics Committee of Milano Area A on date 12/02/2015 by number 0004902. The ethics approval in 2015 included just Stage 1 and Stage 2 patients. In March 2019 additional permission was taken from the same ethical Committee of Milano Area A for inclusion of Stage 3 patients in the study (Protocol numbers 10115/2019 and 13689/2019). This work followed the principles laid down in the Declaration of Helsinki on medical protocol.
: Informed consent was obtained from all individual participants included in the study.
: Not applicable.