Katsube, Takayuki
Miyazaki, Shiro
Narukawa, Yukitoshi
Hernandez-Illas, Martha
Wajima, Toshihiro
Article History
Received: 28 January 2018
Accepted: 27 March 2018
First Online: 7 April 2018
Compliance with ethical standards
:
: Takayuki Katsube, Shiro Miyazaki, Yukitoshi Narukawa, and Toshihiro Wajima are employees of Shionogi. Martha Hernandez-Illas conducted this research at QPS Miami Research Associates, LLC (South Miami, FL, USA) in the course of their employment, and their employers were compensated by Shionogi for conducting this study.
: This study was conducted at QPS Miami Research Associates, South Miami, FL, in accordance with all appropriate regulatory requirements and under the protocol approved by an institutional review board, IntegReview IRB, Austin, TX. This study was conducted in accordance with current International Council for Harmonization (ICH) Good Clinical Practices (GCP), all appropriate subject privacy requirements, and the ethical principles outlined in the Declaration of Helsinki.
: 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 any study related procedures the subjects provided written informed consent and received a copy of the signed consent form to keep as a reference.