AD/TO:01 has completed Pre-clinical, Phase 0 and Phase I studies, and results of these initial studies indicate significant efficacy relative to current therapies. A large, double-blind, placebo-controlled phase IIb trial (funded by the NIH) is currently underway to evaluate the effect of the proprietary combination of topiramate and ondansetron as compared with either drug alone and with placebo, and is due to be completed in 2009. Upon successful completion of this study, a registrational trial (phase III) is scheduled to be launched in 2010.