Furihata, Kenichi
Nagasawa, Katsuaki
Hagino, Atsushi
Kumagai, Yuji
Article History
Received: 17 September 2019
Accepted: 18 January 2020
First Online: 19 February 2020
Compliance with ethical standards
:
: 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. KN and AH were employees of Mochida Pharmaceutical Co., Ltd.
: 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 patients provided written informed consent before starting any procedure in this study. The information of this study was registered with ClinicalTrials.gov (Identifier: NCT03350386).