Koshimichi, Hiroki
Ishibashi, Toru
Kawaguchi, Nao
Sato, Chisako
Kawasaki, Akira
Wajima, Toshihiro
Funding for this research was provided by:
Shionogi
Shionogi
Article History
First Online: 4 October 2018
Compliance with Ethical Standards
:
: This study was sponsored by Shionogi and Co., Ltd. Medical writing assistance was provided by Luke Carey, PhD, and Rebecca Lew, PhD, CMPP of ProScribe—Envision Pharma Group, and was funded by Shionogi and Co., Ltd. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).
: Hiroki Koshimichi, Toru Ishibashi, Nao Kawaguchi, Chisako Sato, Akira Kawasaki and Toshihiro Wajima are employees of Shionogi and Co., Ltd.
: This study was conducted in accordance with current International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, all appropriate subject privacy requirements, and the ethical principles outlined in the Declaration of Helsinki. It was also 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 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, all subjects provided written informed consent and received a copy of the signed consent form to keep as a reference.