Takeshima, Takao
Hirata, Koichi
Igarashi, Hisaka
Sakai, Fumihiko
Sano, Hiromi
Kondo, Hiroyuki
Shibasaki, Yoshiyuki
Koga, Nobuyuki
Article History
Received: 27 September 2023
Accepted: 15 May 2024
First Online: 25 May 2024
Declarations
:
: This study was conducted as an observational study. This study was not, therefore, registered as a clinical trial with the regulatory authorities, and there is no applicable “Clinical Trial Number”.This study used only anonymized data provided by DeSC Healthcare, Inc. Moreover, as Otsuka Pharmaceutical Co., Ltd., Clinical Study Support Inc. (CSS), and the medical experts did not possess or receive data correspondence sheets, it was impossible to identify any individual subject. In addition, DeSC does not have a correspondence table for the data provided to Otsuka Pharmaceutical Co., Ltd, and it is, therefore, impossible to identify individual subjects from the data provided. Therefore, under the Japanese legal regulations, “Ethical Guidelines for Medical and Health Research Involving Human Subjects”, it was judged unnecessary for the study investigators to obtain new individual level consent for the use of the data in this study.The study protocol was approved by the ethics committee of the Research Institute of Healthcare Data Science (approval No.: RI2020012), who on the above stated information judged that the need for consent to participate was deemed unnecessary according to national regulations. Additionally, this study was conducted in consideration of the Declaration of Helsinki (revised October 2013) by the World Medical Association and the Ethical Guidelines for Medical Research Involving Human Subjects.
: Not applicable.
: HS, HK, YS and NK are employees of Otsuka Pharmaceutical Co., Ltd. TT received consulting fees from Otsuka Pharmaceutical Co., Ltd., during the conduct of the study; consulting fees from Otsuka Pharmaceutical Co., Ltd., Hedgehog MedTech, Inc., and Sawai Pharmaceutical Co., Ltd.; honoraria for lectures from Otsuka Pharmaceutical Co., Ltd., Amgen Inc., Eli Lilly Japan K.K., and DAIICHI SANKYO Co., Ltd., outside the submitted work; Clinical trials, contract research and collaborative research funding from Eisai Co., Ltd., Eli Lilly Japan K.K., Shionogi & Co., Ltd., Biohaven Ltd., and Lundbeck Japan K.K. KH received consulting fees from Otsuka Pharmaceutical Co., Ltd., during the conduct of the study; consulting fees from Otsuka Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Astellas BioPharma K.K., Lundbeck Japan K.K., and Sawai Pharmaceutical Co., Ltd.; lecture Honoraria from Otsuka Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Eisai Co., Pfizer Japan, Daiichi Sankyo Co., Ltd., MSD Co., Ltd., Amgen Astellas BioPharma K.K., Ltd., and Lundbeck Japan K.K., outside the submitted work. HI received consulting fees Otsuka Pharmaceutical Co., Ltd., during the conduct of the study; consulting fees from Takeda Pharmaceutical Company Ltd., Otsuka Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Eli Lilly Japan K.K, lecture honoraria from Otsuka Pharmaceutical Co., Ltd., Eli Lilly Japan K.K, Amgen K.K., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., and Sumitomo Pharma Co., Ltd.; manuscript writing fee from Sawai Pharmaceutical Co., Ltd.; educational event fees from Lundbeck Japan K.K., outside the submitted work. FS received consultant fee from Otsuka Pharmaceutical Co., Ltd., during the conduct of the study; consulting fees from Otsuka Pharmaceutical Co., Ltd., Eli-Lilly Co., Ltd., and Amgen Co. Ltd.; lecture Honoraria from Otsuka Pharmaceutical Co., Ltd., Eli-Lilly Co., Ltd., and Amgen Co., Ltd., outside the submitted work.