 2. Patient was at least 18 years of age at the time of screening. Prior to Amendment 1, dated 03 February 2005, this criterion restricted enrollment to patients who were 18 and 65 years of age. To ensure that safe dosing levels were administered to patients 65 years of age, AQUAVAN and midazolam dosing levels were reduced when compared with patients between 18 and 65 years of age, inclusive. The majority of patients were enrolled prior to 03 February 2005. 