Ethics and regulatory approval
MAY
The study was performed in compliance with the requirements of Good Clinical Practice/International Council for Harmonisation (GCP/ICH) Guidelines for clinical trials. The Study gained full board review from Institutional Review Board (IRB) on May 14, 2020, by WCG Aspire IRB. Protocol number Maizinol (UP165) 2020 IRB Tracking number 20201258.