Table 3.

Safety outcomes.

	Treatment N = 145	Control N = 145	p-value	Relative Risk
Deaths at 30 days	0	0	-	-
Unplanned hospitalization at 30 days	6 (4.1%)	4 (2.8%)	0.75	1.5 (0.4, 5.1)
Emergency department visit without hospitalization at 30 days	9 (6.2%)	5 (3.4%)	0.41	1.8 (0.6, 5.3)
Death, hospitalization, or emergency department visit at 30 days	15 (10.3%)	9 (6.2%)	0.29	1.6 (0.7, 3.6)

Hospitalizations and emergency department visits analyzed as yes/no per patient. Only 1 of 10 patients had 2 hospitalizations, and 1 of 14 patients had 2 emergency department visits. No patients had both a hospitalization and emergency department visit. P values using Fisher exact. Relative risk from log-binomial model with fixed site effect.