Arai, Yoko
Okuyama, Kotoba
Onishi, Yoshie
Schelfhout, Jonathan
Tokita, Shigeru
Kubo, Takekazu
Funding for this research was provided by:
MSD K.K.
Article History
Received: 24 February 2022
Accepted: 30 September 2022
First Online: 21 November 2022
Declarations
:
: According to the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology, and Ministry of Health, Labour and Welfare of Japan) (22nd December, 2014 with revision on 28th February, 2017), ethics approval and informed consent are not applicable to this study since the data had been anonymised. Patients were informed that their data would be used for research (opt-out system) and their data were de-identified before being included the database. Pharmacoepidemiological studies using de-identified medical databases constitute research carried out on pre-existing material and information, and do not require any interventions or interactions with patients. For such studies, including this study, the opt-out system without informed consent from patients is allowed according to the above guidelines.
: Not applicable.
: YA, KO, JS, ST and TK are employees of subsidiaries of Merck & Co., Inc., Rahway, NJ, USA (MSD), a pharmaceutical company which markets medications for the treatment of chronic cough. YO is an employee of Creativ-Ceutical, a consultancy company who received funding from MSD K.K., Tokyo, Japan for the implementation of this study.