Mendivil, Joan
DerSarkissian, Maral
Banerji, Aleena
Diwakar, Lavanya
Katelaris, Constance H.
Keith, Paul K.
Kim, Harold
Lacuesta, Gina
Magerl, Markus
Slade, Charlotte
Smith, William B.
Choudhry, Zia
Simon, Angela
Sarda, Sujata P.
Busse, Paula J.
Funding for this research was provided by:
Takeda Development Center Americas, Inc.
Article History
Received: 6 September 2022
Accepted: 16 April 2023
First Online: 29 May 2023
Declarations
:
: Ethics review committees for each clinical site approved the protocol prior to initiation (Australia: Melbourne Health Human Research Ethics Committee, Parkville, VIC [2018.074]. Canada: Hamilton Integrated Research Ethics Board, Hamilton, ON [4037-C]; Nova Scotia Health Authority Research Ethics Board, Halifax, NS [1023307]; Western University Health Science Research Ethics Board, London, ON [110868]. Germany: Charité -Universitätsmedizin Berlin Ethics Committee [EA2/171/18]. Italy: Ospedale Luigi Sacco, Milan, Italy. United Kingdom: HRA and Health and Care Research Wales [247717]. United States: Partners Human Research Committee, Somerville, MA [2017P002434/PHS]; Mount Sinai School of Medicine Institutional Review Board, New York, NY [17-01229]). Written informed consent was obtained only from patients in Germany as required by the site’s review committee.
: Not applicable.
: J. Mendivil was a full-time employee of Takeda Pharmaceuticals International AG at the time of this study. M. DerSarkissian is an employee of Analysis Group. A. Banerji reports institutional research/study support from BioCryst and Takeda, and honoraria for consulting from BioCryst, CSL Behring, KalVista, Pharming, Pharvaris and Takeda. P. J. Busse reports grants from Takeda; a lecture honorarium from CVS Health; and consulting fees from BioCryst, CSL Behring, Pearl Therapeutics, Pharming and Takeda. L. Diwakar reports funding from CSL Behring and Takeda for conference attendance. C. H. Katelaris reports honoraria for lectures and advisory board participation from CSL Behring and Takeda. She also reports institutional funding for clinical trials from BioCryst, CSL Behring and Takeda. P. K. Keith reports research funding and honoraria from CSL Behring and Takeda. H. Kim has served on advisory boards/speaker bureaus for ALK, Aralez, AstraZeneca, CSL Behring, Kaléo, Mylan, Novartis, Pediapharm, Pfizer, Sanofi, Stallergenes Greer and Takeda. G. Lacuesta reports research funding and honoraria from Takeda and honoraria from CSL Behring. M. Magerl reports research grant support and/or speaker/consultancy fees from BioCryst, CSL Behring, KalVista, Octapharma, Pharming and Takeda. C. Slade reports honoraria from Takeda and CSL Ltd for serving as a medical advisor. W. B. Smith reports institutional research/study support from BioCryst and Takeda; honoraria for advisory board participation from CSL Behring and Takeda; and travel grants for symposium attendance from Takeda. A. Simon is a full-time employee of Takeda Development Center Americas and holds stocks/options. Z. Choudhry and S. P. Sarda were employees of Takeda Development Center Americas when this study was conducted.