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Article History

Received: 13 October 2025

Accepted: 20 January 2026

First Online: 28 May 2026

Declarations

Ethical: The study was conducted in accordance with the principles of the Declaration of Helsinki and it has been approved by the Institutional Etichs Commitee of each participating centre.

Human ethics and consent to participate: All patients provided written informed consent prior to study enrollment, in accordance with the Declaration of Helsinki.

Approval of the study: The study was approved by Comitato Etico Unico Regionale c/o Azienda Regionale di Coordinamento per la Salute (ARCS) via Pozzuolo, 330 33100 UDINE.

Competing interests: • M. B.: no disclosure •E. L.: no disclosure • E. R. : no disclosure • J. R.: no disclosure• C. P.: no dislosure • A. A.: no dislosure • F. C.: BeOne, Sobi, Roche, Astrazeneca, Incyte , Lilly, Abbvie, Pierre Fabre, Kyte, Novartis, Gentili (Speaker Bureau/or Advisory Board) • L. B.: no disclosure • G. L.: Janssen Cilag, Roche, Italfarmaco, Incyte, Abbvie, Gilead, Takeda, BeOne, Astrazeneca • A. E.: no disclosure• V. T.: no disclosure • F. Z.: Janssen Cilag, Abbvie, Gilead, Lilly, Amgen, Grifols, Sanofi, Takeda, Novartis, BeOne, Incyte, Astrazeneca.

Clinical trial registration: This study is registered with ClinicalTrials.gov (NCT04251065, first posted on 31 January 2020). The complete study protocol is available from the corresponding author upon request.