,
Akizawa, Tadao
Shimazaki, Ryutaro
Shiramoto, Masanari
Fukagawa, Masafumi
Funding for this research was provided by:
Kyowa Hakko Kirin Co., Ltd
Article History
First Online: 30 August 2018
Compliance with Ethical Standards
:
: TA has received consulting fees from Kyowa Hakko Kirin Co. Ltd., Astellas Pharma Inc., Bayer Yakuhin, Ltd., Fuso Pharmaceutical Industries, Ltd., Japan Tobacco Inc., Ono Pharmaceutical Co. Ltd. and NIPRO Industry, and lecture fees from Kyowa Hakko Kirin Co. Ltd., Chugai Pharmaceutical Co. Ltd., Bayer Yakuhin, Ltd., Kissei Pharmaceutical Co. Ltd., Torii Pharmaceutical Co. Ltd. and Ono Pharmaceutical Co. Ltd. MF has received consulting fees from Kyowa Hakko Kirin Co. Ltd. and Ono Pharmaceutical Co. Ltd.; lecture fees from Kyowa Hakko Kirin Co. Ltd., Bayer Yakuhin, Ltd., Torii Pharmaceutical Co. Ltd. and Ono Pharmaceutical Co. Ltd.; and grants from Kyowa Hakko Kirin Co. Ltd. and Bayer Yakuhin, Ltd. MS has no conflicts of interest to declare. RS is employed by Kyowa Hakko Kirin Co. Ltd., which funded this research.
: Prior to the start of the single-dose and multiple-dose studies, the study protocols were approved by the Hakata Clinic Institutional Review Board. The study was conducted in compliance with the International Ethical Guidelines for Biomedical Research Involving Human Subjects, Good Clinical Practice Guidelines, the Declaration of Helsinki, and local laws.
: This study was sponsored by Kyowa Hakko Kirin Co. Ltd. Medical writing and editorial support was funded by Kyowa Hakko Kirin Co. Ltd.
: All subjects provided written informed consent. The study was conducted at the Hakata Clinic, Fukuoka, Japan.