Rupe, Cosimo
Basco, Alessia
Gioco, Gioele
Patini, Romeo
Lucchese, Alberta
Micciché, Francesco
Massaccesi, Mariangela
Lajolo, Carlo
Funding for this research was provided by:
Università Cattolica del Sacro Cuore
Article History
Received: 28 April 2023
Accepted: 28 September 2023
First Online: 18 October 2023
Declarations
:
: This research was funded by Sunstar Europe S.A., Route de Pallatex 11, P.O. Box 32, 1163 Etoy, Switzerland. (prot. CA-19-0888). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
: The protocol was approved by the ethics committee of the ‘Università Cattolica del Sacro Cuore’ (Ref. 50053/19) and is registered at ClinicalTrials.gov (ID: NCT05103124). The informed consent was carried out in line with the Declaration of Helsinki and was obtained from all subjects involved in the study. Written informed consent approved by the ethics committee (Ref. 50053/19) has been obtained from the patients to publish this paper.