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Article History

Accepted: 23 April 2024

First Online: 13 June 2024

Declarations

:

: This work was supported by Minophagen Pharmaceutical Co., Ltd, Tokyo, Japan.

: Akimichi Morita has received research grants and speakers’ fees from Minophagen Pharmaceutical Co., Ltd. Akimasa Sanagawa, Tomoaki Hayakawa, Aya Yamamoto, Yuji Hotta, and Yoko Furukawa-Hibi have no conflicts of interest to declare in relation to this study.

: This study included a post hoc analysis of data obtained from a previous clinical trial (jRCTs041180094) that was approved by the Ethics Review Boards of Nagoya City University and Osaka City University. All procedures conducted during studies involving human participants were performed in accordance with the ethical standards of the institutional research committee and the 1964 Declaration of Helsinki and its later amendments, as well as with comparable ethical standards. No new samples or clinical or laboratory data were generated during the present study.

: All participants provided written informed consent prior to any study procedure.

: Not applicable.

: The datasets generated and/or analyzed during the study are available from the corresponding author on reasonable request.

: Not applicable.

: AS: Conception and design of the study; data acquisition, analysis and interpretation; drafting the manuscript. TH: Study design; data acquisition, analysis, and interpretation; support for manuscript writing and review. AY: Data acquisition, support for manuscript writing and review. YH: Data interpretation, support for manuscript writing and review. YF: Data interpretation, support for manuscript writing and review. AM: Study design, data acquisition, supervision and support for manuscript writing and review. All authors read and approved the final version of this manuscript for submission.