Pamela Palmer, founder and chief medical officer of AcelRx Pharmaceuticals. ‘We look forward to dealing with the FDA and the Division of Defense to complete the advancement of ARX-04 and provide this novel and far needed product to market.’ The Stage 3 SAP301 trial enrolled adult individuals undergoing outpatient abdominal medical procedures procedures at four clinical sites in the usa. Following surgery, 163 patients were randomized to receive either ARX-04 or placebo in a 2:1 active to placebo ratio. ARX-04 or placebo was administered by site staff as requested by the patient, but only one time per hour. The intent-to-treat population in this research averaged 40.9 years of age with the average Body Mass Index of 27.5, and had a higher % of females to males .Adverse-event rates were compared with the use of Fisher’s exact check. All testing were two-sided, with a P worth of 0.05 thought to indicate statistical significance. No imputations had been made for lacking data. Six – and 12-month analyses had been repeated at 36 months, with all two-sided checks at a 0.05 significance level. Results Study Patients Enrollment began in May 2005 and ended in February 2006. A complete of 501 individuals were enrolled; 251 were randomly assigned to receive alemtuzumab, and 250 to receive conventional therapy . A complete of 474 patients were found to be eligible for the scholarly study and underwent risk stratification. In all, there were 139 high-risk recipients, 70 of whom received alemtuzumab and 69 of whom received rabbit antithymocyte globulin.