Summary of dichotomous efficacy and safety measures.

Measures of response and remission are reported for each treatment. Adverse events measures are reported for events that reached a statistical threshold of pTable 4.aTrials with no events in either study arm are not included in summary OR calculations.bThe 95% confidence interval included the possibility of both treatment-related benefit and treatment-related harm.cBecause the total number of events in the OFC group was higher than the sample size of the group in Shelton et al [27], an effect size could not be calculated, and it was thus not factored into the overall effect size estimate for sedation. Given the very small sample of the study, this makes virtually no difference in the overall effect size estimate.dThe four trials in which edema was reported for OFC participants had an average rate of 18.32%. Edema was not listed as an adverse event in Shelton et al [26] for any participants in either the OFC or placebo group. As these data did not fit with the other OFC trials, we excluded this study from the calculation of the risk for placebo participants.