Rubinstein, Arye
Mabudian, Mohsen
McNeil, Donald
Patel, Niraj C.
Wasserman, Richard L.
Gupta, Sudhir
Carrasco, Paz
Chen, Jie
Garcia, Enrique
Nagy, Andras
Yel, Leman
Article History
Received: 8 March 2024
Accepted: 15 July 2024
First Online: 19 August 2024
Declarations
:
: Prior to patient enrollment, the protocol, informed consent form, any promotional material/advertisements, and any other written information to be provided were reviewed and approved by independent ethics committees, institutional review boards, and applicable regulatory authorities. Ethics committee approval was obtained centrally and locally at each site prior to site initiation.
: All patients and/or their legally authorized representative signed and dated an informed consent form before entering into the study, according to applicable regulatory requirements. Any patient could voluntarily withdraw consent for continued participation and data collection.
: AR, MM, and DMcN have nothing to disclose. NCP receives research funds from the Takeda group of companies and CSL Behring, and is on speakers’ bureaux for the Takeda group of companies, CSL Behring, and Horizon Therapeutics. RLW has received grants and personal fees from ADMA Biologics, CSL Behring, Evolve Biologics, Green Cross BioPharma, Grifols, and the Takeda group of companies, and grants from GC Biopharma, Kedrion, Octapharma, and the Takeda group of companies. SG has received a grant from Takeda for investigator-initiated research, has been an investigator on sponsored clinical trials for Octapharma and Takeda, and has been a consultant for Avilar. PC and AN are employees of Baxalta Innovations GmbH, a Takeda company, and are Takeda shareholders. JC and EG are employees of Takeda Development Center Americas, Inc. LY is a Takeda shareholder and was an employee of Takeda Development Center Americas, Inc. at the time of the study.