Experimental model and study participant details
The study was conducted in accordance with Good Clinical Practice as defined by the International Conference on Harmonization and in line with the ethical principles of the Declaration of Helsinki, European Union Directive 2001/20/EC and the US Code of Federal Regulations, Title 21, Part 50. The clinical protocol, amendments, and informed consent forms were approved by the US FDA and by an independent Ethics Committee, IntegReview IRB (Austin, TX, USA), before study initiation and throughout the study. All participants provided written informed consent and could withdraw from the study at will.