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Article History

Received: 13 November 2017

Accepted: 3 July 2018

First Online: 11 July 2018

Ethics approval and consent to participate

: This was a retrospective study carried out using claims data from the commercial JMDC database; the authors were not involved in the collection of these data and data were anonymized before addition to the research database. Retrieval of the data from this database occurred in an unlinked fashion. As the data had been anonymized, the Ethical Guidelines for Epidemiological Research (Ministry of Education, Culture, Sports, Science and Technology, and Ministry of Health, Labor and Welfare of Japan), which require ethics approval and informed consent, are not applicable to this study. Based on the Ethical Guidelines on Biomedical Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology, and Ministry of Health, Labor and Welfare of Japan), pharmacoepidemiological studies conducted on medical databases qualify as research carried out on pre-existing material and information that do not require any interventions or interactions with patients. For such studies, including this study, obtaining written informed consent from patients is not mandatory. The authors had permission from JMDC to access the database.

: Not applicable.

: JM, and RS were affiliated with Janssen Pharmaceutical KK at the time the study was conducted, a company that develops and markets drugs for the treatment of psoriasis. KI and WT received honoraria from Janssen KK.

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