Table 5.

Infection-related endpoints, ITT population.

Events due to infections	Subjects with at least 1 event [n (%)]	Days (Mean ± SD) (n=49)	Days (Min, Max) (n = 49)
Days missed from work/school/daycare or unable to perform daily activities	25 (51)	7.1 ± 18.04	0, 96
Days of unscheduled visits to physicians	32 (65.3)	2.3 ± 3.75	0, 24
Days of hospitalizations	2 (4.1)	0.1 ± 0.53	0, 3
Yearly hospitalization rate*		0.1 ± 0.31	0, 2
Yearly hospitalization duration†		0.1 ± 0.51	0, 3
Days of antibiotic use‡
IV	1 (2.0)	0.1 ± 0.44	0, 3
Oral	29 (59.2)	13.2 ± 22.09	0, 127

*Yearly Hospitalization Rate=number of hospitalization/subject follow-up time in years.

^†Yearly Hospitalization Duration=total hospitalization duration in days/subject follow-up time in years.

^‡Based on the total number of days of antibiotic use for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject.

IV, intravenous; Max, maximum; Min, minimum; SD, Standard deviation.