Noguchi, Masanori http://orcid.org/0000-0003-2328-4985
Arai, Gaku
Egawa, Shin
Ohyama, Chikara
Naito, Seiji
Matsumoto, Kazumasa
Uemura, Hirotsugu
Nakagawa, Masayuki
Nasu, Yasutomo
Eto, Masatoshi
Suekane, Shigetaka
Sasada, Tetsuro
Shichijo, Shigeki
Yamada, Akira
Kakuma, Tatsuyuki
Itoh, Kyogo
Funding for this research was provided by:
Ministry of Health, Labour and Welfare (ID 2014110358)
Article History
Received: 21 January 2019
Accepted: 21 January 2020
First Online: 5 February 2020
Compliance with ethical standards
:
: Kyogo Itoh received research funding from Taiho Pharmaceutical Company. Akira Yamada is a part-time executive of BrightPath biotherapeutics Co. Ltd. and has stock. Seiji Naito has received honorarium from Sanofi. The remaining authors declare that there are no other conflicts of interest.
: The protocol was approved by institutional review boards or ethical committees at all of the institutions: The Ethical Committee of Kurume University, approval number 213101; The Kitasato Institute, Clinical Research Review Board, approval number 2013002; Okayama University Hospital Ethics Committee, approval number 251001; Dokkyo Medical University Ethical Committee, approval number 1304; The Ethical Committee of Kumamoto University Hospital, approval number 2013701; The Jikei University Certified Review Board, approval number 25-20(2921); The Ethical Committee of Hirosaki University Hospital, approval number Ishi1; Kyushu University Certified Institutional Review Board, approval number 2013301; The Ethical Committee of Kagoshima University Hospital, approval number 2014102; and Kindai University Certified Institutional Review Board, approval number 2013005, and it was registered in the UMIN Clinical Trials Registry (UMIN000011028). The study was carried out in accordance with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice guidelines, and it was conducted in an outpatient setting.
: Written-informed consent to participate in the clinical trial and to use their data for research and publication purpose was received from all individual participants before participating in the study.