Table 2.

Primary and secondary outcomes at 120 days after baseline (n=910)

Outcome at 120 days	Vaccinated group (n=455)	Control group (n=455)*	Difference (95% CI)†
Mean (SD) symptom tool score	13 (9.4)	14.8 (9.8)	MD −1.8 (−3.0 to −0.5)
Remission (%)‡	16.6	7.5	RD 9.1 (5.0 to 13.2)
Mean (SD) impact tool score	24.3 (16.7)	27.6 (16.7)	MD −3.3 (−5.7 to −1.0)
Proportion of patients with impact tool score >PASS (%)	38.9	46.4	RD −7.4 (−14.5 to −0.3)

PASS=Patient Acceptable Symptom State; MD=mean difference; RD=risk difference; CI=confidence interval;SD=standard deviation.

*For 275 patients in the control group, data were censored on the date of their vaccination before 120 days (median delay before censoring 90 days, interquartile range 72.5-105).

†Outcome data were missing for 37 (8.1%) and 32 (7.0%) patients in the vaccinated and control groups, respectively. Missing outcome data were handled by multiple imputations with chained equations.

‡Estimated by the Kaplan-Meier method.