A total of 357 patients received study drug and 78.5 % vs. 65.6 % of patients achieved PGA48 `` success '' for SSTS vs. IV PCA MS , respectively , demonstrating non-inferiority ( P < 0.001 using the one-side Z-test against the non-inferiority margin ) as well as statistical superiority for treatment effect ( P = 0.007 ) .