Ethics approval and consent to participate
ICH
This clinical trial was performed based on ethical principles of the Helsinki Declaration enacted in 1964. The procedure specified in this work was performed based on KGCP (Pharmaceutical Clinical Trial Management Standard, Prime Minister's Ordinance No. 1022, 2013.3.23, ICH E6). The authors declare that this study was registered on the Clinical Research Information Service (CRIS) on 09/21/2022 (registration number KCT0007722) and conducted in accordance with ethics approval from Kyung Hee University Hospital, Seoul, South Korea, KMC IRB No. 1332–05, Apr. 20. 2015, To confirm whether the human application process was conducted in accordance with the KGCP standard and the human body application test plan, a clinical trial agency (CRO) (Global Health Care Co., Ltd) conducted monitoring. During this test, it was checked whether the case records were clear and complete, a comparative review with the record source was performed, and the test manager or the person in charge cooperated with the monitoring person at any time. Before participating in the human study, the participant obtained information from the investigator based on the informed consent statement approved by the IRB about the principle, purpose, and potential risk of this study. The consent to participate in the human application test was obtained by the participant or the representative signing the consent form, and a copy of the signed consent form was distributed to each participant. All participant names were kept confidential, and participants were identified during recording and evaluation by the participant number assigned with participation in the test. The participant was informed that all test data were stored on a computer and treated as strictly confidential information, and the signed consent form was kept by the clinical trial manager of the testing institution after the clinical trial was completed.