Using two-sided Chi-Square tests for assessing three pair-wise differences between the different study arms and applying Bonferroni's correction (i.e., alpha = 0.0166 for each comparison), we sought to collect 97 patients in each arm to achieve 80% power to detect a 22% difference between arms given a baseline uptake of 60%.
When different dose levels were used in different study arms, the study arm with the higher dosage was chosen, and a sensitivity analysis was performed.
Gains on the q arm of chromosome 1 are more frequently reported, but the exact locations vary significantly between different studies.
Finally, completion rates and item missing rates at different time points were not different between study arms, providing further support for the comparability of treatment groups.
Changes in lactate were not statistically different between study arms in the few studies that report this outcome.
The baseline HbA1c values were not significantly different between study arms, but the average baseline value in the CarbCountABC arm was 0.4% lower than in the CarbCount arm.
An analysis of drop in Hb > 3 g/dl shows that Hb decreases were statistically different between study arms (misoprostol 5.1% versus placebo 9.6%, RR 0.53, 95% CI 0.34 0.83).
Also, changes in the level of sICAM-1, MPO, d-dimer, IL-6, or hs-CRP from baseline to weeks 4, 12, and 48, respectively, were not significantly different between study arms.
Delays between symptom onset and intervention did not significantly differ between study arms (data not shown).
