Table 3.

Most common on-treatment AEs (≥ 3% incidence in any treatment group) (ITT population)

	Placebo (n = 101)	FF dose
		200 mcg OD/AM (n = 105)	200 mcg OD/PM (n = 103)	400 mcg OD/AM (n = 111)	400 mcg OD/PM (n = 113)	200 mcg BD (n = 113)
Any AE, n (%)	28 (28)	36 (34)	32 (31)	43 (39)	35 (31)	38 (34)
Headache	6 (6)	8 (8)	7 (7)	10 (9)	7 (6)	9 (8)
Nasopharyngitis	4 (4)	8 (8)	8 (8)	3 (3)	7 (6)	6 (5)
Bronchitis	2 (2)	1 (< 1)	3 (3)	4 (4)	4 (4)	0
Pharyngolaryngeal pain	1 (< 1)	2 (2)	3 (3)	2 (2)	1 (< 1)	3 (3)
Upper respiratory tract infection	2 (2)	3 (3)	2 (2)	2 (2)	1 (< 1)	1 (< 1)
Dysphonia	0	1 (< 1)	1 (< 1)	1 (< 1)	2 (2)	3 (3)
Rhinitis	0	4 (4)	1 (< 1)	0	1 (< 1)	2 (2)
Rhinitis allergic	1 (< 1)	2 (2)	3 (3)	0	0	1 (< 1)
Dizziness	0	3 (3)	0	2 (2)	1 (< 1)	0
Influenza	2 (2)	0	1 (< 1)	3 (3)	0	0
Pharyngitis	4 (4)	2 (2)	0	0	0	0
Respiratory tract infection	0	1 (< 1)	0	3 (3)	1 (< 1)	0

AE = adverse event; AM = morning dosing; BD = twice daily; OD = once daily; PM = evening dosing