Document is current

Article History

Received: 19 October 2023

Accepted: 3 January 2024

First Online: 19 January 2024

Declarations

:

: The trial will be conducted in compliance with the protocol, Food and Drug Administration regulations, International Council for Harmonisation (ICH) Good Clinical Practice Guideline (E6), international ethical principles derived from the Declaration of Helsinki and Council for International Organizations of Medical Science guidelines, and applicable local laws and regulations. The trial site(s) will seek approval by an independent ethics committee according to regional requirements. Written informed consent will be obtained from all participants prior to screening.

: Not applicable — no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials.

: R. D. is an investigator for the study described in this paper, and they and/or their institutions will receive funding support from Otsuka Pharmaceutical Development & Commercialization, Inc. to conduct this study. A. H. D. is an investigator for the study described in this paper, and their institution will receive funding support from Otsuka Pharmaceutical Development & Commercialization, Inc. to conduct this study. S. T., Y. L., B. Z., V. K., and J. H. are employees of Otsuka Pharmaceutical Development & Commercialization, Inc.