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Article History

Received: 3 May 2025

Accepted: 1 October 2025

First Online: 3 November 2025

Declarations

:

: Pier Giorgio Cojutti has received a grant from Angelini and Shionogi, outside of the submitted work. Pierluigi Viale has served as a consultant for Advanz Pharma, Angelini, bioMérieux, Gilead, Merck Sharp & Dohme, InfectoPharm, Pfizer, Shionogi, Thermo-Fisher, Venatorx, and Viatris and served on the speaker’s bureau for Advanz Pharma, Angelini, Gilead, Merck Sharp & Dohme, InfectoPharm, Menarini, Pfizer, Shionogi, and Viatris outside the submitted work. Federico Pea has served as a consultant for Advanz Pharma, Angelini, Gilead, Merck Sharp & Dohme, Pfizer, and Viatris outside the submitted work and participated on speaker’s bureaus for Angelini, Gilead, Menarini, Merck Sharp & Dohme, InfectoPharm, Pfizer, Shionogi, and Viatris outside of the submitted work. Federico Pea is an editorial board member of Clinical Pharmacokinetics and was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The other authors have no conflicts of interest to declare.

: The study was conducted according to the Declaration of Helsinki guidelines and approved by the local ethics committee (no. 882/2021/Oss/AOUBo on 31 January 2022).

: All participants provided informed written consent.

: All participants agreed to the publication policy as per study protocol.

: The data presented in this study are available upon request from the corresponding author.

: The population pharmacokinetic codes are available in the electronic supplementary material.

: All authors contributed to the concept and interpretation of the study. PGC performed the study and curated and analyzed the data. PGC and FP wrote the original manuscript. FP, PV, and EB designed the research and supervised the study. PB, VR, LB, and RS reviewed and commented on the manuscript. All authors read and agreed to the published version of the manuscript.