3.1. Primary endpoint of the study
A total of 355 (174 benzydamine HCl 0.3% spray and 181 benzydamine HCl 3 mg lozenges) patients entered in the efficacy analysis as PP population and 363 patients as m-ITT population (181 benzydamine HCl 0.3% spray and 182 benzydamine HCl 3 mg lozenges). Based on the results, benzydamine HCl spray resulted not inferior to benzydamine HCl lozenges, as the difference between the percentage of patients reporting at least a “slight relief” (STRRS score ≥ 1) at 2 minutes after the administration of benzydamine HCl spray or benzydamine HCl lozenges, did not exceed the threshold of −10% in both the PP (95% CI, −5.18; 6.73) and m-ITT (95% CI, −4.78; 6.88) populations (Table Efficacy analysis of Benzydamine HCl 0.3% spray and Benzydamine HCl 3 mg lozenges in PP and m-ITT populations.BNZ = benzydamine, HCl = hydrochloride, m-ITT = modified intent-to-treat, PP = per-protocol.