Scorcella, C.
Domizi, R.
Amoroso, S.
Carsetti, A.
Casarotta, E.
Castaldo, P.
D’angelo, C.
Damiani, E.
Gasparri, F.
Donati, A.
Adrario, E.
Article History
Received: 3 October 2022
Accepted: 10 February 2023
First Online: 16 February 2023
Declarations
:
: The study protocol was approved by the Local Ethics Committee (Comitato Etico Regione Marche -CERM) and it conformed to the principles of Helsinki declaration. NCT02750163, trial registered on the 25/04/2016. In compliance with national applicable laws, informed consent was obtained from the subjects before inclusion; patients that were temporarily unable to consent for neurological impairment or sedation were included in the study with deferred subject consent and written informative for the next of kin at the time of enrollment (these patients did not belong to groups of vulnerable population).
: Not applicable.
: The authors declare no competing interests.