Mishima, Kazuo
Fujimoto, Kenichi
Endo, Akira
Ishii, Mika
Funding for this research was provided by:
Eisai Co., Ltd.
Article History
Accepted: 9 April 2024
First Online: 6 June 2024
Declarations
:
: This study was funded by Eisai Co., Ltd, Japan.
: Informed consent was obtained from all individual participants included in the study.
: All participants have consented to the submission of the results of this study to <i>Drugs in R&D</i>.
: Kazuo Mishima accepted the role of medical expert for this study from Eisai Co., Ltd, and received compensation. Kenichi Fujimoto, Akira Endo, and Mika Ishii are employees of Eisai Co., Ltd, who conducted this study. The entire costs of implementation, analysis, and publication of this study were borne by Eisai Co., Ltd. This study was conducted as a postmarketing observational study at each medical institution that had signed a contract based on the Ministerial Ordinance on Good Postmarketing Study Practice for Drugs (GPSP Ordinance) and research expenses were paid to the institutions in accordance with the contract.
: The scientific and ethical appropriateness of the plan was discussed by Eisai Co., Ltd and the plan was implemented as the ‘Postmarketing Observational Study of Dayvigo Tablets: Survey on the Occurrence of Adverse Drug Reactions in Insomnia Patients’ in accordance with the Ministerial Ordinance on Good Postmarketing Study Practice for Drugs (GPSP Ordinance).
: The dataset for this study contains data from sites that do not permit third-party provision; therefore, it has not been made publicly available.
: Conceptualization and design: KM, MI. Data acquisition: KF, AE. Data analysis: KF, AE. Data interpretation: KM, KF, AE, MI. Writing (drafting/revising): KM, KF, AE, MI. Approval of the final manuscript: KM, KF, AE, MI.