Solemn Biotech studies are designed and conducted in compliance with applicable laws and regulations, as well as recognized ethical standards such as the Declaration of Helsinki and Good Clinical Practice (GCP). This includes ensuring that clinical research participants are not exposed to unnecessary risks, and that their informed consent is obtained. All clinical investigators and other personnel working on ApoPharma sponsored clinical studies are trained on the study protocol and GCP. We regularly audit and monitor clinical study sites and processes related to our clinical trials.