TABLE 3.

Number (%) of TEAEs reported for ≥3% in any treatment arm of the safety population

Preferred term	TX-004HR 4 μg (n = 191)	TX-004HR 10 μg (n = 191)	TX-004HR 25 μg (n = 190)	Placebo (n = 192)
Any participant with reported TEAE	97 (50.8)	94 (49.2)	93 (48.9)	111 (57.8)
Headache	12 (6.3)	14 (7.3)	6 (3.2)	15 (7.8)
Vaginal discharge	5 (2.6)	6 (3.1)	4 (2.1)	13 (6.8)
Nasopharyngitis	5 (2.6)	6 (3.1)	7 (3.7)	10 (5.2)
Vulvovaginal pruritus	4 (2.1)	3 (1.6)	7 (3.7)	10 (5.2)
Back pain	9 (4.7)	1 (0.5)	4 (2.1)	8 (4.2)
Urinary tract infection	5 (2.6)	5 (2.6)	8 (4.2)	4 (2.1)
Upper respiratory tract infection	5 (2.6)	6 (3.1)	3 (1.6)	5 (2.6)
Oropharyngeal pain	1 (0.5)	0 (0)	6 (3.2)	1 (0.5)

TEAE, treatment-emergent adverse event.