Onozuka, Daisuke
Takatera, Satoko
Matsuo, Hiroo
Yoshida, Hisao
Hamaguchi, Shigeto
Yamamoto, Shungo
Sada, Ryuichi Minoda
Suzuki, Koichiro
Konishi, Keiji
Kutsuna, Satoshi
Funding for this research was provided by:
Earth Corporation, Tokyo, Japan
Article History
Received: 28 December 2023
Accepted: 10 April 2024
First Online: 25 April 2024
Declarations
:
: This open-label, randomized, placebo-controlled clinical trial was approved by the Ethical Committee of Osaka University (No. S22003) on 6/10/2022, and was registered with the Japan Registry of Clinical Trials (jRCT) (No. jRCTs051220107) on 18/10/2022. This trial was conducted in compliance with the provisions of the Declaration of Helsinki, Good Clinical Practice Guidelines, and local regulatory requirements. Patient registration was conducted from 7/11/2022 to 19/1/2023 in Osaka, Japan, and all of the participants provided written informed consent.
: Not applicable.
: S.K., D.O., S.T., and K.K. have received research support from Earth Corporation, Tokyo, Japan. H.M., H.Y., S.H., S.Y., R.M.S., and K.S. declare no competing interests.