2.6. Statistics
DSS, pain
PID, SECONDARY
Benzydamine HCl spray was considered not inferior to benzydamine HCl lozenges if the lower limit of the 2-sided 95% confidence interval (95% CI) of the difference in responder rates between the benzydamine HCl formulations, defined as % of patients reporting at least a “slight relief” (STRRS score ≥ 1) at T2min, did not exceed the threshold of −10%. Assuming a responder rate, defined as percentage of patients reported at least a slight relief (STRRS score ≥ 1), equal to 90% in the benzydamine HCl lozenges arm at T2min, a sample size of 178 patients per group (with a drop-out rate of 20%) was required to claim the noninferiority between treatment groups, using a 2-tailed confidence level of 95%. In this way, the lower bound of the confidence interval (CI) of the difference in the responder rates between the treatment groups should not exceed the threshold of −10.0% with a power of 80%.The Cochran-Mantel-Haenszel test was applied on percentage of patients with a STRRS score ≥ 1 at 1 minute after the single dose administration and on percentage of patients with a STRRS score ≥ 3 at 5, 10, 15, 30, 60, and 120 minutes after the single dose administration.ANCOVA or ANOVA were applied on: the sum of pain intensity differences (SPID) for DSS and SwoTS, estimated as the area under the pain intensity difference (PID) versus time curve up to 2 hours postdose (the PID was calculated by subtracting the baseline pain intensity score from the actual pain intensity score); the total pain relief for STRRS, estimated as the area under the pain relief versus time curve by adding the pain relief scores observed 2 to 240 minutes postdose; QuaSTI at 60 and 120 minutes postdose; TPA; STPIS. Covariate used in ANCOVA was the baseline value. Scores were reported as mean ± standard deviation (SD).Descriptive statistics was applied to PSQ at the end of the treatment, to vital signs and their change from V0 and to change from baseline in physical examination presented by treatment group.Confidence intervals and statistical tests for secondary endpoints were of descriptive nature.