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Article History

Received: 10 July 2024

Accepted: 17 December 2024

First Online: 9 January 2025

Declarations

:

: WAW reports grants paid to his institution from Boehringer Ingelheim, Galapagos, Roche, and Alentis. FB has served as an advisor or review panel member for Boehringer Ingelheim, Bristol Myers Squibb (BMS), Fujirebio, Galapagos, GlaxoSmithKline (GSK), Roche, and Takeda; received fees for speaking from Boehringer Ingelheim, Fujirebio, Galapagos, and Roche; and support for travel from Boehringer Ingelheim and Roche. NC reports consulting fees from Boehringer Ingelheim, Bridge Therapeutics, Liminal BioSciences, Redex, Transcript, and Vicore and fees for speaking from Boehringer Ingelheim. FV reports consulting fees from Boehringer Ingelheim and fees for speaking from Boehringer Ingelheim and Roche. DA-O reports grants from Boehringer Ingelheim, FibroGen, Galapagos, Galecto, Genentech/Roche, and Pliant. JWS reports grants from the National Research Foundation of Korea, the Korea National Institute of Health, and the Korea Environment Industry & Technology Institute; he reports fees for speaking from Boehringer Ingelheim, BMS, and Eisai; and has served as a consultant and steering committee member for Boehringer Ingelheim, Taiho, and Daewoong. CM is an employee of mainanalytics GmbH, Sulzbach (Taunus), Germany, which was contracted by Boehringer Ingelheim to assist with these analyses. MD and CC are employees of Boehringer Ingelheim. VC reports grants from Boehringer Ingelheim; fees for speaking from Boehringer Ingelheim, Roche, and Ferrer; consulting fees from Boehringer Ingelheim, Celgene/BMS, CSL Behring, Ferrer, Galapagos, GSK, Pliant, PureTech, Redx, Roche, Sanofi, and Shionogi; has served as an advisor or review panel member for Celgene/BMS, FibroGen, Galapagos, Galecto, Roche; and has received support for travel from Boehringer Ingelheim, Ferrer, and Roche.

: The INBUILD and INBUILD-ON trials were conducted in accordance with the principles of the Declaration of Helsinki and the Harmonised Tripartite Guideline for Good Clinical Practice from the International Conference on Harmonisation. The study protocols were reviewed and approved by an Independent Ethics Committee and/or Institutional Review Board at each trial site.

: All patients provided written informed consent before study entry.

: Not applicable.