Document is current

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.