Kumagai, Yuji
Sakaki, Masashi
Furihata, Kenichi
Ito, Takayoshi
Inoue, Kazuaki
Yoshida, Takafumi
Matsumoto, Shigeki
Furuno, Kazuki
Hagino, Atsushi
Article History
Received: 18 September 2019
Accepted: 31 October 2019
First Online: 23 November 2019
Compliance with ethical standards
:
: This study was conducted according to the Declaration of Helsinki, International Committee on Harmonization Good Clinical Practice guideline, and applicable local laws and regulations. The protocol was approved by the regulatory authorities in Japan and by the ethics committees of study centre. All subjects provided written informed consent before starting any procedure in this study. The information of this study was registered with ClinicalTrials.gov (Identifier: NCT03306667).
: YK received honoraria unrelated to this study from TEIJIN PHARMA LIMITED. KF received consultant fees unrelated to this study from Kissei Pharmaceutical Co., Ltd. and SRL, Inc. KF, SM and AH were employees of Mochida Pharmaceutical Co., Ltd.
: This article is distributed under the terms of the Creative Commons Attribution 4.0 international license (ExternalRef removed), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.