4.8. Ethics of the Clinical Trial
ICH
The entire clinical study was meticulously conducted in strict adherence to the highest standards of ethical and scientific conduct. The study’s execution followed the principles of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), both of which are firmly established frameworks for ensuring the integrity and reliability of clinical research. These practices were aligned with the guidelines set forth by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), particularly ICH E6 [R2]. Local regulatory standards were strictly respected, as were the most recent versions of the World Medical Association and the Declaration of Helsinki. These guidelines collectively ensure the protection of participants’ rights, well-being, and data integrity throughout the study. The study underwent a rigorous ethical review and was granted approval by the Institutional Review Board (IRB) of Seoul Bumin Hospital (IRB number: BE_20_033, Seoul, Republic of Korea). Furthermore, before engaging in any study-related procedures, all participants were provided with a thorough explanation of the study’s purpose, design, procedures, and potential risks and benefits. This transparent disclosure allowed participants to make informed decisions about their involvement. To formally indicate their informed consent and willingness to participate, each participant signed a written informed consent document.