Table 2.

Adverse events by randomization group and age category

Randomization group	7-day removal group, n (%)			Spontaneous group, n (%)			Total, n (%, 95% CI)
	10–15 years (n=57)	>15 years (n=57)	Total (n=114)	10–15 years (n=58)	>15 years (n=58)	Total (n=116)	10–15 years (n=115)	>15 years (n=115)	Total (n=230)
Total AEs	2 (3.5)	4 (7.4)	6 (5.3)	2 (3.4)	0 (0)	2 (1.7)	4 (3.5)	4 (3.5)	8 (3.5, 1.1–5.8)
Severity of AE
Severe	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0, 0–0)
Moderate	2 (3.5)	4 (7.4)	6 (5.3)	2 (3.4)	0 (0)	2 (1.7)	4 (3.5)	4 (3.5)	8 (3.5, 1.1–5.8)
Type of AE
Edema	2 (100)	0 (0)	2 (33.3)	2 (100)	0 (0)	2 (100)	4 (100)	0 (0)	4 (50.0)
Infection	0 (0)	4 (100)	4 (66.7)	0 (0)	0 (0)	0 (0)	0 (0)	4 (100)	4 (50.0)

Any event was counted only once using highest severity. No participant had more than one AE. There were no differences between randomization groups or age categories. AE: adverse event; CI: confidence interval