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Article History

Received: 13 July 2024

Accepted: 14 January 2025

First Online: 4 February 2025

Declarations

:

: The study will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the Clinical Trials Act, and all of the applicable regulatory requirements. This study protocol was first authorized by the institutional review committee on December 21, 2022 at the Kobe University Graduate School of Medicine. Participant recruitment began on January 1, 2023. This study was registered at the jRCT on December 27, 2022 (jRCT2051220143). Ethical approval was obtained for the trial (approved on January 18, 2023, at Hamamatsu University Hospital and February 6, 2023, at Hiroshima University Hospital.). The details of the study are available at the following address: . Written informed consent will be obtained from all participants before any study procedure is performed. All patients will review the consent form and agree that they fully understand the details of the study procedures. Informed consent will be administered by a suitably qualified and experienced individual who will be delegated this duty by the principal investigator. Any protocol changes that could have an impact on study conduct and/or participant risk-benefit profile, including changes in objectives, design, sample size, participant characteristics, staff changes, or significant administrative aspects, will require approval from the Institutional Review Board. Minor protocol corrections and/or clarifications that could not affect study conduct or the participant risk-benefit profile will be viewed as administrative changes and documented internally. De-identified data will be made available to other interested investigators for additional analyses, on reasonable request, following reports of primary outcomes and with appropriate data use agreement. The findings of this study will be disseminated through scientific and professional conferences and a peer-reviewed journal.

: Not applicable.

: Toshiro Shirakawa is CEO of Immunorock Co., Ltd., the manufacturer of B440. The remaining authors declare no competing interests.