FDC FDC Aclidinium Formoterol Parameter Placebo 400/12 µg 400/6 µg 400 µg 12 µg HCRU rate 0.36 0.26 0.29 0.29 0.41 (0.23, 0.54) (0.19, 0.36) (0.21, 0.39) (0.21, 0.40) (0.31, 0.54) RR vs placebo - 0.73 0.80 0.82 1.15 (0.4, 1.2) (0.5, 1.4) (0.5, 1.4) (0.7, 1.9) RR vs aclidinium 400 µg - 0.89 0.98 - - (0.6, 1.4) (0.6, 1.5) RR vs formoterol 12 µg - 0.64 0.70 - - (0.4, (0.5, 1.1) 1.0)† EXACT rate 1.54 1.09 1.28 1.40 1.26 (1.2, 1.9) (0.9, 1.3) (1.1, 1.5) (1.2, 1.6) (1.1, 1.5) RR vs placebo - 0.71 0.83 0.91 0.82 (0.5, 0.9)* (0.6, 1.1) (0.7, 1.2) (0.6, 1.1) 0.78 0.91 RR vs aclidinium 400 µg - - - (0.6, (0.7, 1.1) 1.0)‡ RR vs formoterol 12 µg - 0.86 1.01 - - (0.7, 1.1) (0.8, 1.3)
Parameter Placebo FDC 400/12 µg FDC 400/6 µg Aclidinium 400 µg Formoterol 12 µg HCRU rate 0.36 (0.23, 0.54) 0.26 (0.19, 0.36) 0.29 (0.21, 0.39) 0.29 (0.21, 0.40) 0.41 (0.31, 0.54) RR vs placebo - 0.73 (0.4, 1.2) 0.80 (0.5, 1.4) 0.82 (0.5, 1.4) 1.15 (0.7, 1.9) RR vs aclidinium 400 µg - 0.89 (0.6, 1.4) 0.98 (0.6, 1.5) - - RR vs formoterol 12 µg - 0.64 (0.4, 1.0)† 0.70 (0.5, 1.1) - - EXACT rate 1.54 (1.2, 1.9) 1.09 (0.9, 1.3) 1.28 (1.1, 1.5) 1.40 (1.2, 1.6) 1.26 (1.1, 1.5) RR vs placebo - 0.71 (0.5, 0.9)* 0.83 (0.6, 1.1) 0.91 (0.7, 1.2) 0.82 (0.6, 1.1) RR vs aclidinium 400 µg - 0.78 (0.6, 1.0)‡ 0.91 (0.7, 1.1) - - RR vs formoterol 12 µg - 0.86 (0.7, 1.1) 1.01 (0.8, 1.3) - -
12890_2014_628_MOESM1_ESM.docx