Funding for this research was provided by:
Boehringer Ingelheim (1402-0008)
Article History
Accepted: 13 March 2024
First Online: 24 April 2024
Declarations
:
: This study was funded by Boehringer Ingelheim (BI study number 1402-0008; NCT03875001). The funders of the study had a role in the study design, data analysis, data interpretation, and writing of the report.
: AH is an employee of Nippon Boehringer Ingelheim Co., Ltd. JY was an employee of Nippon Boehringer Ingelheim Co., Ltd at the time of the study conduct. VS was an employee of Boehringer Ingelheim International GmbH at the time of the study conduct. Authors did not receive any direct compensation relating to the development of the manuscript.
: The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.
: Not applicable.
: The study was carried out in accordance with the principles of the Declaration of Helsinki, the International Conference for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, and Boehringer Ingelheim standard operating procedures. The study protocol, the subject information form and the informed consent form were reviewed and approved by the institutional review board of the Souseikai Hakata Clinic, Fukuoka, Japan on 22 March 2019.
: All participants provided informed written consent in accordance with ICH GCP and local procedures.
: The informed consent form included permission to publish.
: JY, AH, and VS contributed to the study concept and design, and were responsible for data analyses and interpretation. All authors contributed towards the preparation of the manuscript, approved the final submitted version, and agreed to be listed as authors.