Kawaguchi, Nao
Koshimichi, Hiroki
Ishibashi, Toru
Wajima, Toshihiro
Funding for this research was provided by:
Shionogi (JP)
Shionogi
Article History
First Online: 10 September 2018
Compliance with Ethical Standards
:
: This study was funded by Shionogi & Co., Ltd.
: Nao Kawaguchi, Hiroki Koshimichi, Toru Ishibashi, and Toshihiro Wajima are employees of Shionogi & Co., Ltd.
: This study was conducted in accordance with current International Conference on Harmonisation Good Clinical Practice, all appropriate subject privacy requirements, and the ethical principles outlined in the Declaration of Helsinki. This study was conducted in accordance with all appropriate regulatory requirements and under a protocol approved by the institutional review board of the study site, Souseikai Hakata Clinic, Fukuoka, Japan.
: Prior to enrollment, subjects received a full explanation of the nature and the objectives of the study, the safety of the drugs under investigation, and that they were free to withdraw from the study at any time without prejudice. Prior to the initiation of study-related procedures, the subjects provided written informed consent and received a copy of the signed consent form to keep as a reference.