Study organization and oversight
The study was conducted in compliance with the Protocol at 15 clinical trial sites in the United States and Canada, as well as recognized international standards including the Good Clinical Practice guidelines of the International Conference on Harmonisation and the principles of the Declaration of Helsinki. The Protocol and its amendments were approved by the institutional review board of each participating trial site. Voluntary written informed consent was obtained from every patient before participation in this study. DNX-2401 preparation, handling and administration followed institutional standards for biosafety level 2 agents.