Wada, Takashi
Hosoya, Tatsuo
Honda, Daisuke http://orcid.org/0000-0001-5624-7553
Sakamoto, Ryusuke
Narita, Kazutaka
Sasaki, Tomomitsu
Okui, Daisuke
Kimura, Kenjiro
Article History
Received: 12 September 2017
Accepted: 4 January 2018
First Online: 25 January 2018
Compliance with ethical standards
:
: The study protocol and informed consent document were reviewed and approved by health authority in Japan (Pharmaceuticals and Medical Devices Agency) and the investigation review board of each medical institution. Informed consent was obtained from all individual participants included in the study. The tests were conducted in compliance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, Good Clinical Practice guidelines, and other regulatory requirements to be applied. The information of this study was registered with Clinical Trials.gov (ClinicalTrials.gov number: NCT02327754).
: SKK and Fuji Yakuhin Co., Ltd. (Fuji) sponsored this study. TW, TH, KK were advisors to SKK and Fuji regarding this study and received consultant fees. TH’s laboratory has received research fund from SKK and Fuji. DH, RS, KN were employees of SKK. TS, DO were employees of Fuji.