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Article History

Accepted: 2 July 2025

First Online: 18 July 2025

Declarations

:

: Open access funding provided by Università degli Studi di Milano - Bicocca within the CRUI-CARE Agreement. The study is funded by AIFA within the 2016 call for Independent Research on Drugs (Bando AIFA per la Ricerca Indipendente 2016); code: 2016–0234923. The study Sponsor had no role in study design; in the collection, management, analysis, and interpretation of data; in writing the report; and in the decision to submit the report for publication. The study Sponsor had no ultimate authority over any of the listed activities.

: F.B. has received direct or indirect consultant fees from Angelini, Rovi and IQVIA Solutions, and honoraria for editorial activities from Elsevier and AVES. S.C. has received consultant fees from Lundbeck, Otsuka, Angelini and Johnson & Johnson. G.M. has received research grants, consulting fees and honoraria from Angelini, Doc Generici, Janssen-Cilag, Lundbeck, Neuraxpharm, Otsuka, Pfizer, Servier, Rovi and Recordati. MSS has received consultant fees from Lundbeck and Angelini. Other authors reported no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

: The study was first approved for the coordinating centre (University of Verona) by the Ethics Committee for Clinical Research of Verona and Rovigo (protocol 61211 of the 19 September 2018; protocol version 1.5 of the 09 June 2018) and thereafter by the local ethics committee of each recruiting centre. The study was performed in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki).

: All participants signed a written informed consent form.

: Not applicable.

: The dataset will be made available upon motivated request.

: Not applicable.

: All authors have read and approved the final submitted manuscript and agree to be accountable for the work. F.B.: Conceptualization; Methodology; Validation; Formal Analysis; Data Curation; Writing - Original Draft. D.C.: Investigation; Writing – Original Draft; Visualization. I.R.: Investigation; Writing – Original Draft; Visualization. T.C.: Investigation; Data curation; Writing – Review and Editing. C.Cr.: Methodology; Formal Analysis; Writing – Original Draft. C.G.: Investigation; Resources; Writing – Review and Editing. A.A.: Investigation; Writing – Review and Editing. C.Ca.: Investigation; Writing – Review and Editing. S.Ca.: Investigation; Writing – Review and Editing. S.Ch.: Investigation; Writing – Review and Editing. M.C.: Investigation; Writing – Review and Editing. A.D.: Investigation; Writing – Review and Editing. I.E.: Investigation; Writing – Review and Editing. L.G.: Investigation; Writing – Review and Editing. M.I.: Investigation; Writing – Review and Editing. S.M.: Investigation; Writing – Review and Editing. G.M.: Investigation; Writing – Review and Editing. M.R.: Investigation; Writing – Review and Editing. A.R.: Investigation; Writing – Review and Editing. R.R.: Investigation; Writing – Review and Editing. V.R.: Investigation; Writing – Review and Editing. C.S.G.: Investigation; Writing – Review and Editing. M.S.S.: Investigation; Writing – Review and Editing. L.T.: Investigation; Writing – Review and Editing. G.O.: Validation; Investigation; Resources; Writing – Review and Editing; Project administration; Funding acquisition. G.C.: Methodology; Writing – Original Draft; Supervision.