Funding for this research was provided by:
Received: 10 March 2022
Accepted: 18 July 2022
First Online: 7 August 2022
: Institutional review board approval was obtained centrally (by Advarra), and locally at each site prior to site initiation. The study is registered on ClinicalTrials.gov under the identifier NCT03716700. All patients provided written informed consent prior to study enrollment.
: Not applicable.
: PKK has received personal fees from Novartis, Aralez Pharmaceuticals, Pediapharm, AstraZeneca, Shire, CSL Behring, Kaleo, Merck, GlaxoSmithKline, Mylan, ALK, Sanofi, and Stallergenes and grants from AstraZeneca, CSL Behring, Genentech, and Shire. JCo has received research funding not related to this study from CSL Behring, Grifols, and Octapharma. She has received speaker fees from Octapharma, GSK, EMD Serono, and Alexion Pharma. She has received educational funding from Takeda. AK has received personal fees from Novartis, Aralez Pharmaceuticals, Pediapharm, Takeda, CSL Behring, and Mylan. He has received grants from Genentech and Takeda. HK has been on speakers’ bureaus and/or advisory boards for ALK, AstraZeneca, Aralez, CSL Behring, Kaleo, Merck, Mylan, Novartis, Pediapharm, Sanofi, and Shire. He has received research funding from AstraZeneca, Shire, and Novartis. GL has participated in research with Takeda. She has received speaker fees from Takeda, CSL Behring, Novartis, AstraZeneca, and Mylan. She has participated in advisory boards for Takeda, CSL Behring, Octapharma, Sanofi, GSK, and AstraZeneca; and was sponsored to attend international meetings with Shire/Takeda, AstraZeneca, and GSK. JKL has received speaker fees from ALK, Paladin, Novartis, AstraZeneca, Sanofi, Astellas, GSK, Takeda, Merck, CSL Behring, Omega, Sanofi Genzyme, Mylan, Meda, Pediapharm, Aralez, Paladin, Pfizer, and Stallergenes. He has received grants and research funding from Immunodeficiency Canada, AstraZeneca, ALK, Aralez, Paladin, Novartis, Sanofi, CSL Behring, GSK, Pediapharm, Stallergenes, Roche-Genentech, PPD, Shire, Takeda, Trudell Medical, Bausch and Lomb, and Regeneron. He has participated in advisory boards for GSK, Novartis, AstraZeneca, Merck, CSL Behring, Teva, Sanofi Genzyme, Mylan, ALK, Meda, Pediapharm, Paladin, Regeneron, AbbVie, and Genentech. He has been a consultant for GSK, AstraZeneca, Novartis, Regeneron, and Sanofi Genzyme. JCh and MP are employees of Takeda Development Center Americas, Inc. and are Takeda shareholders. AG is an employee of Takeda Pharmaceuticals International AG and a Takeda shareholder.