Gupta, Sudhir http://orcid.org/0000-0001-7422-1453
DeAngelo, James
Melamed, Isaac
Walter, Jolan E.
Kobayashi, Ai-Lan
Bridges, Tracy
Sublett, J. Wesley
Bernstein, Jonathan A.
Koterba, Alan
Manning, Michael
Maltese, Joanna
Hoeller, Sonja
Turpel-Kantor, Eva
Kreuwel, Huub
Kobayashi, Roger H.
Funding for this research was provided by:
Octapharma
Article History
Received: 16 March 2023
Accepted: 3 May 2023
First Online: 9 May 2023
Declarations
:
: This study was carried out in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and in accordance with the 1964 Declaration of Helsinki and its later amendments. The clinical study protocol and all amendments were approved by the Institutional Review Boards and Independent Ethics Committees of the participating Centers.
: All patients provided written and signed informed consent at each participating center. The authors affirm that human research participants or their legal guardians provided informed consent for participation and publication of their individual details.
: Sudhir Gupta was an investigator in this trial, has received grant funding from the University of California, Irvine, and serves as a consultant for Avilar Therapeutics. James De Angelo, Isaac Melamed, Jolan E. Water, Ai Lan Kobayashi, Tracy Bridges, J. Wesley Sublett, Alan Koterba, and Michael Manning were investigators in this trial. Jonathan Bernstein was an investigator in this trial and has also received additional grants, research support, and honoraria from Allakos, Amgen, A&Z Pharmaceutical, Biocryst Pharmaceuticals, Biomarin, Celldex Therapeutics, CSL Behring, Genentech, GlaxoSmithKline, Intellia Therapeutics, Ionis Pharmaceuticals, Kalvista Pharma, Merck, Novartis, the Pharming Group, Pharvaris, Sanofi, Shire, and Takeda. Roger Kobayashi was an investigator in this trial and has also received additional grants, research support, and honoraria from Octapharma and the Vietnamese Respiratory Society. Joanna Maltese, Sonja Hoeller, Eva Turpel-Kantor, and Huub Kreuwel are employees of the trial sponsor, Octapharma.