Miyake, Makito http://orcid.org/0000-0001-9503-7356
Nishimura, Nobutaka
Inoue, Takashi
Suzuki, Shota
Fujii, Tomomi
Owari, Takuya
Hori, Shunta
Nakai, Yasushi
Toritsuka, Michihiro
Nakagawa, Hitoshi
Tsukamoto, Shinji
Anai, Satoshi
Torimoto, Kazumasa
Yoneda, Tatsuo
Tanaka, Nobumichi
Fujimoto, Kiyohide
Article History
Received: 17 October 2020
Accepted: 2 February 2021
First Online: 12 February 2021
Ethics approval and consent to participate
: This clinical trial complied with the Declaration of Helsinki regarding investigation in humans. Its ethical clearance, protocol (version 1.0 on July 31, 2020), and associated documents were approved by the Ethics Committee of Nara Medical University before recruitment (Approval ID: 2702). Informed consent and written consent forms of patients are mandatory before study participation. MM, SH, YN, SA, KT, NT, and KF will obtain informed consent from potential trial participants. Participants are given additional consent for potential use of the trial dataset in future studies, such as systematic review and meta-analysis.
: Not required.
: The authors declare that there are no potential competing interests for the publication of this article.