Nagy, Andras http://orcid.org/0000-0002-7197-6858
Duff, Kimberly http://orcid.org/0009-0000-3657-5293
Bauer, Alexander http://orcid.org/0000-0002-1611-5879
Okonneh, Fred http://orcid.org/0009-0000-9231-2068
Rondon, Juan Carlos
Yel, Leman http://orcid.org/0000-0001-8357-3186
Li, Zhaoyang http://orcid.org/0000-0003-4625-1107
Funding for this research was provided by:
Takeda Development Center Americas, Inc.
Baxalta Innovations GmbH, a Takeda company
Article History
Received: 10 July 2023
Accepted: 27 November 2023
First Online: 22 December 2023
Declarations
:
: This study was conducted in accordance with current applicable regulations including the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, 1996; ICH E6 R2, 2018), Title 21 of the US Code of Federal Regulations, the European Union Directives 2001/20/EC and 2005/28/EC, the Declaration of Helsinki, and applicable national and local regulatory requirements.
: All participants provided informed, written consent to participate in the study.
: All participants provided informed consent for publication of images of infusion site reactions included in this manuscript. Apart from these images, no identifying individual participants’ data are included in this manuscript.
: AN and AB are employees of Baxalta Innovations GmbH, a Takeda company, and are Takeda shareholders. KD, FO, and ZL are employees of Takeda Development Center Americas, Inc., and are Takeda shareholders. JCR has nothing to disclose. LY was an employee of Takeda Development Center Americas, Inc., at the time of the study and is a Takeda shareholder.