Document is current

Article History

Received: 26 March 2024

Accepted: 27 January 2025

First Online: 6 February 2025

Declarations

:

: This study protocol was approved by the Certified Review Board, Tottori University Hospital on 30 January 2024 (version 1.3, approval number: 23C004), and the study is registered in the JRCT ID (registration number: jRCTs061230064, 29 September 2023; ). Any changes to the study protocol, informed consent form (see Additional file 1 for an approved informed consent form), or other study-related documents will need to be approved by the Certified Review Board. After receiving approval, the principal investigator will notify investigators at each study site. This study will be conducted in compliance with the Declaration of Helsinki, Clinical Trials Act (Act No. 16, 2017), and Act on the Protection of Personal Information (Act No. 57, 2003). Investigators will explain the study and obtain written informed consent from all participants prior to the start of any study-related procedures.

: Not applicable.

: FT, YO, TH, and JK received honoraria as a speaker and consultant fee from ASKA Pharmaceutical Co., Ltd. The principal investigators will receive research grant from ASKA Pharmaceutical Co., Ltd. MF is an employee of ASKA Pharmaceutical Co., Ltd.