Capece, Umberto
Pavanello, Chiara
Cinti, Francesca
Leccisotti, Lucia
Mezza, Teresa
Ciccarelli, Gea
Moffa, Simona
Di Giuseppe, Gianfranco
Soldovieri, Laura
Brunetti, Michela
Giordano, Alessandro
Giaccari, Andrea http://orcid.org/0000-0002-7462-7792
Calabresi, Laura
Ossoli, Alice
Article History
Received: 1 August 2023
Accepted: 9 October 2023
First Online: 26 October 2023
Declarations
:
: Umberto Capece, Chiara Pavanello, Francesca Cinti, Lucia Leccisotti, Teresa Mezza, Gea Ciccarelli, Simona Moffa, Gianfranco di Giuseppe, Laura Soldovieri, Michela Brunetti, Alessandro Giordano, Andrea Giaccari, Laura Calabresi and Alice Ossoli have nothing to disclose.
: The trial has been designed to ensure adherence to Good Clinical Practice guidelines as described in (1) ExternalRef removed documents/scientific-guideline/ich-e-6-r2-guide line-good-clinical-practice-step-5_en.pdf and according to (2) EU Directive 2001/20/EC, 2005/28/EC (ExternalRef removed man-use/clinical-trials/directive_en); (3) Declaration of Helsinki 1964, and its amendments and subsequent clarification. A copy of the approval was archived in the study master file in the local study file of the Investigator. The study has also been submitted to and approved by the Hospital/University Ethics Committee (Fondazione Policlinico Universitario A. Gemelli—Università Cattolica del Sacro Cuore. Study Protocol Code GIA-DAP-16–005). Informed, written consent was obtained from all participants.