Document Classification

Section Type: RESULTS

Text: The rates of treatment-related AEs between the first and second doses of study medication were significantly lower for FDC ibuprofen 400 mg/paracetamol 1000 mg (8/149 patients [5. 4 %]) than for placebo (14/73 [19. 2 %] ; P < 0. 01) and paracetamol 1000 mg (10/74 [13. 5 %] ; P < 0. 05) ; and also lower for FDC ibuprofen 200 mg/paracetamol 500 mg (9/143 [6. 3 %]) compared with ibuprofen 200 mg (12/75 [16. 0 %] ; P < 0. 05) and paracetamol 500 mg (17/76 [22. 4 %] ; P < 0. 001).