During the study treatment period, the subject may continue to receive standardized treatment and be assessed. The study treatment period will be approximately 3 hours in length. Safety and efficacy will be monitored throughout the treatment period. PK parameters (if applicable) will be obtained from subjects at selected study sites. A blood sample for genomic evaluation will be collected during the treatment period (at participating sites) if the subject consents to the evaluation. An initial 24-hour post-randomization follow-up visit will be completed to evaluate the subject's health status as well as for safety and PK parameters (if applicable). A second follow-up contact will be completed by telephone seven days post-randomization for safety purposes and to evaluate the subject's health status.