Li, Zhaoyang http://orcid.org/0000-0003-4625-1107
Nagy, Andras
Lindner, Dirk
Duff, Kim http://orcid.org/0009-0000-3657-5293
Garcia, Enrique
Ay, Hakan
Rondon, Juan Carlos
Yel, Leman http://orcid.org/0000-0001-8357-3186
Funding for this research was provided by:
Baxalta Innovations GmbH, a Takeda company (Baxalta Innovations GmbH, a Takeda company)
Baxalta US, Inc (Baxalta US, Inc)
Takeda Pharmaceuticals International AG (Takeda Pharmaceuticals International AG)
Article History
Received: 28 July 2023
Accepted: 24 May 2024
First Online: 19 June 2024
Change Date: 10 July 2024
Change Type: Update
Change Details: The original version of this paper was updated due to revised supplementary material.
Declarations
:
: ZL, DL, KD, EG, and HA are employees of Takeda Development Center Americas, Inc. and are Takeda shareholders. AN is an employee of Baxalta Innovations GmbH, a Takeda company, and is a Takeda shareholder. JCR has no conflict of interest to disclose. LY is a Takeda shareholder, and was an employee of Takeda Development Center Americas, Inc. at the time of the study.
: The study protocol, protocol amendment, the informed consent document, relevant supporting information, and participant recruitment information were submitted and approved by IntegReview Institutional Review Board on May 26, 2020. This study was conducted in accordance with the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, 1996; ICH GCP R2, November 2016), Title 21 of the United States (US) Code of Federal Regulations, the European Union (EU) 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.
: No identifying individual participants’ data are included in this manuscript.