Table 6.

Respiratory, thoracic, and mediastinal AEs during treatment Part B

AE	IN Benzhydrocodone/APAP,	IN Hydrocodone/APAP,	Placebo*
	(N = 44)	(N = 43)	(N = 42)
	No. (%)	No. (%)	No. (%)
Any AE of interest	29 (65.9)	9 (20.9)	10 (23.8
Nasal discomfort	16 (34.4)	2 (4.7)	2 (4.8)
Nasal congestion	7 (15.9)	2 (4.7)	6 (14.3)
Rhinorrhea	7 (15.9)	4 (9.3)	3 (7.1)
Throat irritation	6 (13.6)	3 (7.0)	0
Oropharyngeal pain	1 (2.3)	1 (2.3)	1 (2.4)
Dry throat	1 (2.3)	0	0
Upper airway cough syndrome	0	1 (2.3)	0

AE = adverse event; APAP = acetaminophen; IN = intranasal.

^*Placebo was administered both IN and orally. Each IN active treatment was co-administered with oral placebo.