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Article History

Received: 25 April 2022

Accepted: 21 November 2022

First Online: 2 December 2022

Declarations

:

: This trial will be performed in accordance with the Declaration of Helsinki and Korean Good Clinical Practice Guidelines. The protocol of this trial was approved by the Institutional Review Board of Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2021–12-004) and the Korean Ministry of Food and Drug Safety (32756) and is registered at the Korean Clinical Trial Registry (). The current protocol version (3.1) was approved on March 29th, 2022 and developed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement (see Additional file ). All items were drawn from the World Health Organization Trial Registration Dataset. All modifications to the protocol will be approved by the institutional review board before implementation. Signed informed consent will be obtained from all qualified participants by a clinical research coordinator and/or study investigators. Participation in this study is voluntary, and participants can withdraw from the study at any given point.

: Not applicable.

: The authors have no competing interests to declare.