OR vs formoterol 12 µg - 1.19 1.20 - - (0.81, 1.74) (0.82, 1.77) SGRQ total score, LS mean -6.51 -7.16 -8.34 -5.80 -5.58 (-8.53, -4.49) (-8.54, -5.79) (-9.72, -6.96) (-7.19, -4.41) (-6.96, -4.20) Difference vs placebo - -0.65 -1.83 0.71 0.93 (-3.08, 1.78) (-4.26, 0.60) (-1.73, 3.15) (-1.50, 3.37) Difference vs aclidinium 400 µg - -1.36 -2.54 - - (-3.30, 0.58) (-4.48, -0.59)‡ Difference vs formoterol 12 µg - -1.59 -2.76 - - (-3.52, 0.35) (-4.70, -0.82)†† Data are presented as LS means or OR (95% CI). *p<0.05; **p<0.01; ***p<0.001 vs vs vs formoterol. placebo; ‡p<0.05 aclidinium. ††p<0.01 FDC, aclidinium/formoterol fixed-dose combination; ITT, intention-to-treat; LS, least squares; OR, odds ratio; TDI, Transition Dyspnoea Index; SGRQ, St George’s Respiratory Questionnaire. Additional File 1: Table S3. Rate of COPD exacerbations (any severity) per patient per year based on HCRU and EXACT definitions (ITT exacerbation population).
OR vs formoterol 12 µg - 1.19 (0.81, 1.74) 1.20 (0.82, 1.77) - - SGRQ total score, LS mean -6.51 (-8.53, -4.49) -7.16 (-8.54, -5.79) -8.34 (-9.72, -6.96) -5.80 (-7.19, -4.41) -5.58 (-6.96, -4.20) Difference vs placebo - -0.65 (-3.08, 1.78) -1.83 (-4.26, 0.60) 0.71 (-1.73, 3.15) 0.93 (-1.50, 3.37) Difference vs aclidinium 400 µg - -1.36 (-3.30, 0.58) -2.54 (-4.48, -0.59)‡ - - Difference vs formoterol 12 µg - -1.59 (-3.52, 0.35) -2.76 (-4.70, -0.82)†† - - Data are presented as LS means or OR (95% CI). *p<0.05; **p<0.01; ***p<0.001 vs placebo; ‡p<0.05 vs aclidinium. ††p<0.01 vs formoterol. FDC, aclidinium/formoterol fixed-dose combination; ITT, intention-to-treat; LS, least squares; OR, odds ratio; TDI, Transition Dyspnoea Index; SGRQ, St George’s Respiratory Questionnaire. Additional File 1: Table S3. Rate of COPD exacerbations (any severity) per patient per year based on HCRU and EXACT definitions (ITT exacerbation population).