TABLE 4.

Adverse events (safety population)

n (%)	Placebo (n = 271)	Estradiol (n = 277)
At least 1 TEAE	135 (49.8)	145 (52.3)
At least 1 treatment-related TEAE	58 (21.4)	57 (20.6)
TEAEs leading to discontinuation	6 (2.2)	8 (2.9)
Serious TEAEs	1 (0.4)	3 (1.1)
Deaths	0	0
TEAEs occurring ≥5% participants in the estradiol treatment group
Vulvovaginal mycotic infection	9 (3.3)	19 (6.9)

This table presents the number (%) of participants with at least one event in the respective category. Related TEAEs are events reported with “possible” or “probable” relationship to study drug.

TEAE, treatment-emergent adverse event.