Ethics Approval
ICH
This study was conducted in accordance with current applicable regulations including the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, 1996; ICH E6 R2, 2018), Title 21 of the US Code of Federal Regulations, the European Union Directives 2001/20/EC and 2005/28/EC, the Declaration of Helsinki, and applicable national and local regulatory requirements.