We have hired and trained all necessary staff. We have received HRPO approval. We obtained IRB approval and continued review approval from JHU IRB and also IRB waivers from our primary recruitment sites (Union Memorial Hospital and University of Maryland Medical Center/ShockTrauma. The placebo purchase agreement and material transfer agreement have been agreed on and signed by JHU and Thera technologies responsible officials. We have enrolled and screened our first patient to the trial.