Costa, Gianluca
,
Fransvea, Pietro
Podda, Mauro http://orcid.org/0000-0001-9941-0883
Pisanu, Adolfo
Carrano, Francesco Maria
Iossa, Angelo
Balducci, Genoveffa
Agresta, Ferdinando
Article History
Received: 27 October 2019
Accepted: 13 February 2020
First Online: 22 February 2020
Compliance with ethical standards
:
: Gianluca Costa, Pietro Fransvea, Mauro Podda, Adolfo Pisanu, Francesco Maria Carrano, Angelo Iossa, Genoveffa Balducci, <i>and</i> Ferdinando Agresta, have no conflict of interest to declare. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
: The study has been approved by the Ethics Committee of the University “La Sapienza” (Rome, Italy. Protocol ID: Rif_CE_452_2016). Secondary approval was obtained from all ethics committees of the other participating centers. The study protocol was registered at ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT02825082).
: The study has been performed in accordance with the ethical standards of the institutional and/or national research committee, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.