Abstract S60 Table 1

Change from baseline in morning pre-dose (trough) FEV₁ at Week 24 and rate of exacerbations by concomitant ICS use

	AB/FF 400/12 μg BID	AB/FF 400/6 μg BID	AB 400 μg BID	FF 12 μg BID	Placebo BID

LS mean change from baseline in morning pre-dose (trough) FEV₁ at Week 24 by ICS use, mL^a
ICS use	98***	47***	44***	27**	-47
No ICS use	85***	71***	71***	18***	-50
Rate of exacerbations per patient/year by ICS use^b
ICS use	0.40*	0.53	0.59	0.45	0.67
No ICS use	0.31	0.27	0.29	0.44	0.36

↵^aAnalyses based on the mixed model for repeated measures: treatment effects and treatment comparisons.
↵^bAnalysis based on the log-linear model.
↵*p < 0.05 vs placebo; **p < 0.01 vs placebo; ***p < 0.0001 vs placebo.
AB, aclidinium bromide; BID, twice daily; FEV₁, forced expiratory volume in 1 s; FF, formoterol fumarate; ICS, inhaled corticosteroid; LS, least squares.