Document is current

Article History

Accepted: 28 December 2021

First Online: 18 January 2022

Declarations

:

: Eli Lilly purchased the study report that is the basis for this article. The manuscript was developed with Eli Lilly and CliCon S.r.l.

: VP, EG, DS, and LDE report no conflicts of interest related to this work. The agreement signed by CliCon S.r.l. and Eli Lilly does not create any entityship, joint venture, or any similar relationship between parties. CliCon S.r.l. is an independent company. Neither CliCon S.r.l. nor any of their representatives are employees of Eli Lilly for any purpose. SL, AM, and SA are employees of Eli Lilly Italy S.p.a., Italy. MG is an employee of Eli Lilly S.p.a. & Company Roma, Italy.

: All data used for the current study are available upon reasonable request to CliCon S.r.l., which is the body entitled to data treatment and analysis by Local Health Units.

: Not applicable.

: The following ethics committees were notified of this study and approved the study: <i>Comitato Etico per la Sperimentazione Clinica delle province di Verona e Rovigo</i> (Ref. N. 52045), approval date 25/7/2018; <i>Comitato Etico Sezione Area Centro</i> (Ref. N. 43), approval date 22/02/2019; <i>Comitato Etico ASL Lecce</i> (Ref. N. 29), approval date 11/2/2019; <i>Comitato Etico Regione Abruzzo Avezzano-Sulmona-L’Aquila</i> (Ref. N. 0040036/19), approval date 22/11/2018; <i>Comitato Etico Indipendente “AOU “Consorziale Policlinico”</i> (Ref. N. 0059036), approval date 09/07/2019; <i>Comitato etico interprovinciale Area 1</i> (Ref. N71/SegCE/2019), approval date 18/09/2019.

: Not applicable.

: Not applicable.

: Conceptualization: VP and LDE; data curation: VP and LDE; funding acquisition: LDE; methodology: DS; supervision: LDE; visualization: LDE; writing—original draft: VP and EG; writing—review and editing: VP, SL, AM, SA, and M.G. All authors have read and approved the final version of the manuscript.