Fukumoto, Seiji
Murata, Tatsunori
Osuga, Yutaka
Pollock, Richard F. http://orcid.org/0000-0002-9873-7507
Funding for this research was provided by:
Pharmacosmos A/S
Article History
Received: 9 September 2022
Accepted: 21 June 2023
First Online: 13 September 2023
Declarations
:
: Richard F Pollock is a director of Covalence Research Ltd, which received consultancy fees from Pharmacosmos A/S to conduct the study and write the manuscript. Seiji Fukumoto received a fee from Pharmacosmos A/S for clinical consultancy work in 2021. Tatsunori Murata and Yutaka Osuga have no conflicts of interest to disclose.
: All data used in the analyses were obtained from previously-conducted studies and the analyses are not reliant on data from studies of human or animal participants conducted by any of the authors. Both the JapicCTI-194573 and Ikuta et al. 2019 RCTs, on which the present analysis is based, were approved by the institutional review boards (IRBs) at each participating site. Written informed consent for participation in the studies was obtained from all subjects and both studies were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.