Muto, Satoru
Okada, Tadashi
Shibasaki, Yoshiyuki
Ibuki, Tatsuki
Horie, Shigeo
Funding for this research was provided by:
Otsuka Pharmaceutical
Article History
Received: 25 December 2019
Accepted: 17 May 2021
First Online: 4 June 2021
Declarations
:
: SM and SH have received research funding, honoraria for presentations, paid travels, and consulting and advisory board fees from Otsuka Pharmaceutical Co., Ltd., Japan, and belong to an endowed department sponsored by Otsuka Pharmaceutical Co., Ltd., Japan. In addition, SH has been a medical advisor of the TEMPO-EXTJ trial. TO and YS are employees of Otsuka Pharmaceutical Co., Ltd., Japan, and TI is a former employee of Otsuka Pharmaceutical Co., Ltd., Japan.
: These trials were conducted in accordance with ethical principles originating from the Declaration of Helsinki and in compliance with good clinical practice guidelines. The protocols were approved by the institutional review board at each trial site. The first IRB approval was issued by Niigata University (IRB approval number: CH22-010). Written informed consent was obtained from all participating patients.