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Two hundred and fifty-eight patients with radiologically confirmed acute sinusitis were enrolled by 52 investigators; 216 patients (83.7%) qualified for per protocol efficacy analysis (group 1, n = 175; group 2, n = 41), and 92 for bacteriological analysis. Samples were collected from the middle meatus. The clinical success rate 7-10 days post-treatment was 92.6%. Bacteriological success rates were 95.7% after 3-4 days of treatment, and 97.2% and 95.2%, in group 1 and group 2, respectively, at 7-10 days post-treatment. Drug-related adverse events, including abdominal pain (2.4%), nausea (2.4%) and diarrhoea (1.2%), were reported in 12.2% of patients. 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