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Authors
Miyake, Makito
Nishimura, Nobutaka
Oda, Yuki
Tomizawa, Mitsuru
Shimizu, Takuto
Owari, Takuya
Gotoh, Daisuke
Itami, Yoshitaka
Nakahama, Tomonori
Yoshikawa, Motokiyo
Fujimoto, Ken
Tomioka, Atsushi
Anai, Satoshi
Fujii, Tomomi
Fujimoto, Kiyohide
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Funding
Funding for this research was provided by:
Clinical Research Promotion Program grant of Nara Medical University (JHR2100001)
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Article History
Received: 31 December 2025
Accepted: 14 February 2026
First Online: 5 March 2026
Disclosure
: Miyake M. and Fujimoto K. received 5-aminolevulinic acid hydrochloride from SBI Pharmaceuticals Co., Ltd. during the performance of the study. Both authors received a joint research fund from SBI Pharmaceuticals Co., Ltd. outside the submitted study (the AMBER study; the Japan Registry of Clinical Trials ID jRCTs051190077). The remaining authors have no disclosure.
: This clinical trial complied with the Declaration of Helsinki regarding investigation in humans. Its ethical clearance and protocol (version 1.0 on 21 June 2021), including the subject information, informed consent forms, and associated documents, were approved by the Certified Review Board of Nara Medical University (institution ID: CRB5200002).
: Informed consent and written consent forms of patients are mandatory before study participation. This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 28 June 2021 (reference no. jRCTs051210042). This trial complied with the Declaration of Helsinki for human investigations.
