Raghu, Ganesh http://orcid.org/0000-0001-7506-6643
Hamblin, Mark J.
Brown, A. Whitney
Golden, Jeffrey A.
Ho, Lawrence A.
Wijsenbeek, Marlies S.
Vasakova, Martina
Pesci, Alberto
Antin-Ozerkis, Danielle E.
Meyer, Keith C.
Kreuter, Michael
Burgess, Tracy
Kamath, Nikhil
Donaldson, Francis
Richeldi, Luca
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 6 December 2021
Accepted: 10 May 2022
First Online: 21 May 2022
Declarations
:
: This trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The trial and clinical protocol was approved by the following local/central ethics committees or institutional review boards: <i>Netherlands:</i> Medisch Ethische Toetsings Commissie Erasmus MC, Erasmus MC. <i>Germany:</i> Ethik-Kommission Medizinische Fakultät Heidelberg, Universität Heidelberg; Ethik‐Kommission des Fachbereiches Medizin, Justus-Liebig-Universität Gießen; Ethik‐Kommission, Universität Duisburg‐Essen; <i>Czech Republic</i>: Eticka komise IKEM a TN, Fakultní Thomayerova Nemocnice. <i>Spain:</i> Research Ethics Committee for Medicinal Products, Hospital Universitari de Bellvitge; <i>Italy:</i> Azienda Ospedaliero-Universitaria Policlinico Vittorio; Comitato Etico, AO San Gerardo; <i>Switzerland:</i> Commission Cantonale d’ethique de la recherche sur l'etre‐humain, Canton du Vaud; <i>USA</i>: Western Institutional Review Board (WIRB); Human Investigation Committee, Yale University; Human Research Protection Program IRB, University of California San Francisco; Human Research Protection Program IRB, University of Kansas Medical Center; University of Texas Southwestern Medical School IRB; University of Louisville Human Subjects Protection; Partners Human Research Committee, Partners Healthcare. Written informed consent to participate in the study was obtained from each patient or caregiver. An independent data and safety monitoring board provided oversight.
: Not applicable.
: GR received support to his institution from Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.) for study costs for the clinical trial; has received personal fees and other from Boehringer Ingelheim; consulting fees from Promedior and Veracyte; and other from Fibrogen, Roche-Genentech, Biogen, Bristol Myers Squibb, Bellerophon, and Nitto.MJH has received research grant support from Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.) during the conduct of the study; and outside the submitted work: a clinical trial research grant and a medical education grant from Boehringer Ingelheim, and clinical trial research grants from Roche-Genentech, Biogen, Fibrogen, and Global Blood Therapeutics; and personal fees from Boehringer Ingelheim and Roche-Genentech for serving as a contracted speaker.AWB has received grants and personal fees from Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.) during the conduct of the study; and receipt of personal fees from Roche-Genentech (advisory board and speaker’s bureau), Theravance Biopharma (consulting fees), and Pilot for IPF (honorarium for curriculum development for CME programs) outside the submitted work.JAG has received a research support grant from Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.).LAH has received personal fees from Roche-Genentech and Boehringer Ingelheim for serving on an advisory board.MSW has received unrestricted grants and speaker fees from Boehringer Ingelheim and F. Hoffmann-La Roche, Ltd., and advisory board/consulting fees from Galapagos, Novartis, Horizon, Bristol Myers Squibb, Galecto, and Respivant. All grants and fees were paid to the Erasmus University Medical Center in Rotterdam, Netherlands.MV has received grants to her institution from Boehringer Ingelheim and F. Hoffmann-La Roche, Ltd., and consulting fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Roche-Genentech.AP has received personal fees and support grants to his institution from Boehringer Ingelheim and Roche-Genentech.DEAO has received grants to her institution from Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.) during the conduct of the study and grants from Roche-Genentech, Fibrogen, Boehringer Ingelheim, Biogen, Pliant, and Galecto outside the submitted work (clinical trial grants paid directly to Yale University).KCM has received research grants from the National Institutes of Health (NIH), Roche-Genentech, Parion, Nivalis, and Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.); and personal fees for speaking engagements from the University of Nebraska and Practice Point Communications and National Jewish Health.MK has received independent grants to his institution and personal fees from F. Hoffmann-La Roche, Ltd. and Boehringer Ingelheim, and personal fees for consulting work from AstraZeneca, GlaxoSmithKline, Galapagos, and Chiesi. MK’s institution has received research support from F. Hoffmann-La Roche, Ltd. and Boehringer Ingelheim.TB is an employee of Roche-Genentech.NK is an employee of F. Hoffmann-La Roche, Ltd.FD is an employee of F. Hoffmann-La Roche, Ltd.LR has received personal fees from F. Hoffmann-La Roche, Ltd., Fibrogen, Promedior (now a fully owned subsidiary of F. Hoffmann-La Roche, Ltd.; advisory board member), Sanofi, ImmuneWorks, Celgene, Nitto, Bristol Myers Squibb (consulting), Shionogi (speaker), Boehringer Ingelheim (steering committee), and DynaMed (editorial activity).