For the primary endpoint analysis, intraindividual differences between treatment and control group in the 2HPG value obtained during an OGTT from baseline to 3 months were assessed in the per protocol population. Using two-sided testing and a standard deviation of 20% in relative changes of 2HPG OGTT glucose values, a¼0.05 and b¼0.2, a sample size of 16 patients per group was chosen to detect a difference in 2HPG of 20mg/dL when comparing baseline levels to levels on months 3. SPSS 19 (SPSS, Inc., Chicago, IL) was used for all statistical analyses.
For the primary endpoint analysis, intraindividual differences between treatment and control group in the 2HPG value obtained during an OGTT from baseline to 3 months were assessed in the per protocol population. Using two-sided testing and a standard deviation of 20% in relative changes of 2HPG OGTT glucose values, a¼0.05 and b¼0.2, a sample size of 16 patients per group was chosen to detect a difference in 2HPG of 20mg/dL when comparing baseline levels to levels on months 3. SPSS 19 (SPSS, Inc., Chicago, IL) was used for all statistical analyses.
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