Sugimoto, Yuna
Yamamura, Kayo
Takayama, Tomoyo
Fukuta, Yasuhiko
Aoki, Kazuo
Mikami, Katsunaka
Tomoda, Akemi
Article History
Received: 25 January 2021
Accepted: 6 April 2021
First Online: 22 April 2021
Declarations
:
: This surveillance was conducted in compliance with the Ministerial Ordinance on Standards for Conducting Post-marketing Surveys and Studies on Drugs; MHLW Ordinance No. 171 issued on December 20, 2004 (GPSP). As the surveillance is a non-interventional study in accordance with GPSP, the need for ethics approval and consent were waived. The surveillance was designed by Otsuka, reviewed by the Japanese Pharmaceutical and Medical Devices Agency (PMDA).
: Not applicable.
: This study was funded by Otsuka Pharmaceutical Co., Ltd. KM and AT have received consulting fees from Otsuka Pharmaceutical Co., Ltd. based on contract. YS, KY, TT, YF and KA are employees of Otsuka Pharmaceutical Co., Ltd. KM has received: a) research support from Grant-in-Aid for Scientific Research (C) (Grant Number 18 K07611), Taisho Pharmaceutical, Otsuka Pharmaceutical, Shionogi & Co., Japanese Society for Probiotic Science; b) honoraria from Otsuka Pharmaceutical, Shionogi & Co., Shire Japan, Eli Lilly and Co., Meiji Holdings Co., Takeda Pharmaceutical, MIYARISAN PHARMACEUTICAL CO; and c) a consulting fee from Shionogi & Co and Viatris.