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Article History

Accepted: 17 February 2025

First Online: 16 March 2025

Declarations

:

: The OBELICS trial was supported by a research grant from the Italian Ministry of Health (RF-2009-1539464).

: Gerardo Rosati, Maria Carmela Piccirillo, Guglielmo Nasti, Alfonso De Stefano, Chiara Carlomagno, Carmela Romano, Antonino Cassata, Lucrezia Silvestro, Anna Nappi, Franco Perrone, Alfredo Budillon, and Antonio Avallone declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

: The protocol of the OBELICS trial was approved by local ethics review boards and was conducted according to the Declaration of Helsinki and the International Conference of Harmonisation Good Clinical Practice guidelines. The OBELICS study was registered at EudraCT (reg. no. 2011-004997-27).

: All participants or a proxy provided written informed consent.

: Not applicable.

: Not applicable.

: Not applicable.

: Study concepts—G.R. and A.A.; study design—G.R., A.A., M.C.P., F.P., and A.B.; data acquisition—G.R., A.A., G.N., A.D.S., C.C., C.R., A.C., L.S., and A.N.; quality control of data and algorithms—G.R., C.C., A.A., and M.C.P.; data analysis and interpretation—G.R., M.C.P., and A.A.; statistical analysis—M.C.P.; manuscript preparation—G.R., A.D.S, and M.C.P.; manuscript editing—G.R. and M.C.P.; manuscript review—all authors.