Nocerino, Rita https://orcid.org/0000-0003-4681-546X
Di Scala, Carmen
Coppola, Serena
Giglio, Veronica
Carucci, Laura
Cosenza, Linda
Voto, Luana
Iannicelli, Anna Maria
Luzzetti, Anna
Berni Canani, Roberto
Funding for this research was provided by:
Humana SpA
Article History
Received: 16 July 2020
Accepted: 31 May 2021
First Online: 3 July 2021
Declarations
:
: The study protocol, the subject information sheet, the informed consent form, and the clinical chart were reviewed and approved by the Ethics Committee of the University of Naples Federico II. Institution. The study was conducted in accordance with the Helsinki Declaration (Fortaleza revision 2013), the Good Clinical Practice Standards (CPMP/ICH/135/95), and the current Decree-Law 196/2003 regarding personal data and all the requirements set out in the European regulations on this subject. The study is a part of a project and was registered in the ClinicalTrials.gov Protocol Registration System with the ID number NCT03909113.
: Not applicable.
: The authors have no conflicts of interest that are directly relevant to the content of this paper, which remains their sole responsibility.