Table 3.

Patients (%) reporting adverse events, overall and most common (> 2 patients in any treatment group; Safety population)

Patients (%)	CHF6001 800 μg BID (N = 58)	CHF6001 1600 μg BID (N = 59)	Placebo (N = 58)
Adverse events	30 (51.7)	33 (55.9)	26 (44.8)
Nasopharyngitis	5 (8.6)	6 (10.2)	8 (13.8)
Cough	1 (1.7)	3 (5.1)	1 (1.7)
Oropharyngeal pain	3 (5.2)	2 (3.4)	0
Back pain	4 (6.9)	1 (1.7)	2 (3.4)
Toothache	3 (5.2)	1 (1.7)	2 (3.4)
Diarrhoea	3 (5.2)	1 (1.7)	0
Headache	1 (1.7)	7 (11.9)	1 (1.7)
Tension headache	1 (1.7)	3 (5.1)	0
Fatigue	1 (1.7)	3 (5.1)	0
Drug-related adverse events	1 (1.7)	1 (1.7)	0
Dry mouth	0	1 (1.7)	0
Sleep disorders	1 (1.7)	0	0
Serious adverse events	2 (3.4)	2 (3.4)	2 (3.4)
Drug-related serious adverse events	0	0	0
Severe adverse events	0	1 (1.7)	1 (1.7)
Adverse events leading to study drug withdrawal	3 (5.2)	2 (3.4)	1 (1.7)
Adverse events with a fatal outcome	0	0	0

Abbreviation: BID twice daily