Hayashi, Terumasa
,
Uemura, Yukari
Kumagai, Michiko http://orcid.org/0000-0003-2501-2027
Kimpara, Masashi
Kanno, Hiroyuki
Ohashi, Yasuo
Article History
Received: 5 March 2018
Accepted: 24 September 2018
First Online: 5 October 2018
Compliance with ethical standards
:
: Employment/Leadership position/Advisory role: YO (Statcom), MKu (Chugai), MKi (Chugai), HK (Chugai). Stock ownership or options: YO (Statcom). Honoraria: TH (Kyowa Hakko Kirin, Chugai), YU (Chugai), YO (Chugai, Daiicchi-Sankyo, Sanofi). Research funding: YO (Eisai, Yakult Honsya).
: A third-party central institutional review board (Ai-Research Co., Ltd.) approved the study protocol (Approval no. 70), and the study was conducted in accordance with the Declaration of Helsinki and Japanese Ministry of Health, Labour and Welfare regulations for post-marketing surveillance.
: This study was also registered in advance at the University Hospital Medical Information Network Center (ID: UMIN000008568).
: This study was conducted in compliance with Good Post-Marketing Study Practice (GPSP) standards defined by the Japanese Ministry of Health, Labour and Welfare, which does not require informed consent. A third-party central institutional review board (Ai-Research Co., Ltd.) approved the ethical integrity of the study protocol.