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Clinical Trial Summary

This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.


Clinical Trial Description

This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02722863
Study type Observational
Source Korea Otsuka Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase
Start date July 9, 2013
Completion date June 15, 2017