Horie, Shigeo http://orcid.org/0000-0002-8612-8368
Muto, Satoru
Kawano, Haruna
Okada, Tadashi
Shibasaki, Yoshiyuki
Nakajima, Koji
Ibuki, Tatsuki
Funding for this research was provided by:
Otsuka Pharmaceutical Co., Ltd.
Article History
Received: 2 June 2020
Accepted: 2 December 2020
First Online: 20 January 2021
Compliance with ethical standards
:
: S.H. has received advisory board fees, lecture fees, and grant support as an endowed department from Otsuka Pharmaceutical Co., Ltd. and advisory board fees from Sanofi. S.M. has received lecture fees from Otsuka Pharmaceutical Co., Ltd. and belongs to an endowed department sponsored by Otsuka Pharmaceutical Co., Ltd. H.K. belongs to an endowed department sponsored by Otsuka Pharmaceutical Co., Ltd. T.O., Y.S., and T.I. are full-time employees of Otsuka Pharmaceutical Co., Ltd. K.N. is a former employee of Otsuka Pharmaceutical Co., Ltd.
: TEMPO 3:4 was conducted in accordance with the ethical principles originating in the Declaration of Helsinki and in compliance with good clinical practice guidelines. The protocol was approved by the institutional review board (IRB) at each trial site. The first patient was enrolled in Niigata University Medical and Dental Hospital (IRB approval number: CH19-002a).
: Written informed consent was obtained from all participating patients.