Shinozaki, Katsunori http://orcid.org/0000-0003-0596-3423
Yamada, Takeshi
Nasu, Junichiro
Matsumoto, Toshihiko
Yuasa, Yasuhiro
Shiraishi, Takeshi
Nagano, Hiroaki
Moriyama, Ichiro
Fujiwara, Toshiyoshi
Miguchi, Masashi
Yoshida, Ryosuke
Nozaka, Kimiyasu
Tanioka, Hiroaki
Nagasaka, Takeshi
Kurisu, Yasuro
Kobayashi, Michiya
Tsuchihashi, Kenji
Inukai, Michio
Kikuchi, Takashi
Nishina, Tomohiro
Funding for this research was provided by:
Yakult Honsha
Article History
Received: 16 August 2020
Accepted: 9 October 2020
First Online: 23 October 2020
Compliance with ethical standards
:
: KS has received speaker’s honoraria from Chugai Pharmaceutical Co., Ltd., outside the submitted work; MK has received research funding from Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., outside the submitted work. TN has received honoraria from Taiho Pharmaceutical Co., Ltd., and research funding from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb K.K., Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd., MSD K.K., Sumitomo Dainippon pharma Co., Ltd., outside the submitted work. TY, JN, TM, YY, TS, HN, IM, TF, MM, RY, KN, HT, TN, YK, KT, MI and TK declares no conflicts of interest.
: This study was conducted by the Translational Research Center for Medical Innovation (TRI) in accordance with the Declaration of Helsinki and Clinical Trials Act in Japan. The study protocol was approved by the Institutional Review Board of each participating institution and Certified Review Board. All patients provided written informed consent. This study was registered with UMIN Clinical Trial Registry (Trial Identifier UMIN000017102), the Japan Registry of Clinical Trials (jRCTs061180021), and ClinicalTrials.gov (NCT02497157).
: Informed consent was obtained from all individual participants included in this study.
: The datasets generated during the current study are not publicly available because the informed consent form signed by the participants did not address an individual data sharing statement.