A total of 204 participants were randomly assigned to HB-C (n = 75), HB-PU (n = 85), or HB-P (n = 44). At 12 weeks, 16 of 69 (23%, 95% CI: 14–35%) in the HB-C group, 15 of 69 (22%, 95% CI: 13–33%) in the HB-PU group, and 5 of 31 (16%, 95% CI: 5–34%) in the HB-P group were classified as having a successful outcome. The difference in the percentage of participants with a successful outcome in the HB-C group compared with the HB-PU group was −4% (two-sided 97.5% CI: −19 to +11%; p = 0.56) and with the HB-P group was +5% (two-sided 97.5% CI: −12 to +22%; p = 0.52), adjusted for baseline levels of the composite outcome components.
The majority of participants with symptomatic CI did not have a successful outcome at 12 weeks. Some participants treated with placebo were successful. With recruitment reaching only 34% of that originally planned and differential loss to follow-up among groups, estimates of success are not precise and comparisons across groups are difficult to interpret.