3.3. Safety evaluation
Safety analyses were based on the SP and was evaluated by monitoring frequency of AEs and changes from baseline in physical examination and vital signs. Both benzydamine HCl formulations were well tolerated and showed a good safety profile, without clinically significant abnormalities. No clinically relevant changes from baseline or relevant differences between treatment groups were observed for vital signs and physical examination.Moreover, 30 TEAEs were documented in 22 patients (one in benzydamine HCl spray arm, 21 in benzydamine HCl lozenges arm); 9 TEAEs were classified as mild, and all were resolved. None of them was serious or led to withdrawal.