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.