Shin, Hee-Yeon
Kim, Jeong-Hwa
Jahng, Geon-Ho
Jung, Woo-Sang
Park, Seong-Uk
Ko, Chang-Nam
Park, Jung-Mi http://orcid.org/0000-0002-0851-4431
Funding for this research was provided by:
Korea Health Industry Development Institute (HI16C2352)
Article History
Received: 15 January 2018
Accepted: 10 July 2019
First Online: 22 July 2019
Ethics approval and consent to participate
: The trial will be carried out in accordance with the Declaration of Helsinki and the Korean Good Clinical Practice Guidelines. The trial has been approved by the Institutional Review Board of Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2016–12–006-006) and the Korean Ministry of Food and Drug Safety (31234), and is registered at the Korean Clinical Trial Registry (Registration number: KCT0002407, URL: ExternalRef removed). The current protocol version (1.5) was approved on 13 December 2018, and developed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement (see Additional file InternalRef removed). All items from the World Health Organization Trial Registration Data Set have been drawn. Any modifications to the protocol will be approved by the Institutional Review Board before being implemented. Signed informed consent will be obtained from all qualified participants. Participation in this study is completely voluntary, and participants can withdraw from the study any time.
: Not applicable.
: The authors declare that they have no competing interests.