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Article History

Received: 12 April 2019

Accepted: 4 November 2019

First Online: 6 January 2020

Ethics approval and consent to participate

: The study will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of Good Clinical Practice (GCP), and all of the applicable regulatory requirements.Ethics approval is overseen by the Kobe University Clinical Research Ethics Committee (reference number C180046). Written informed consent will be obtained from all participants before any study procedure is performed. The participant (and/or parent) will have the opportunity to review the Participant Consent Form and agree that they fully understand the details of the study procedures. Informed consent will be administered by a suitably qualified and experienced individual who has been delegated this duty by the principal investigator.

: The Participant Consent Form was approved by the Kobe University Clinical Research Ethics Committee to inform participants and their families that the results will be submitted for publication in a scientific journal. Participants will not be identifiable in any publications. The results will be disseminated via presentations to the community and publication in peer-reviewed journals.

: MH received honoraria as a consultant and speaker from Taiho Pharmaceutical Co., Ltd.The other authors declare that they have no competing interests.