Statistical analyses
SECONDARY
In part A, the sample size of eight in each study group would provide more than 80% power to detect 19% difference between treatment groups for the primary endpoint, with a two-sided significance level of 0.1 (corresponding to 90% CI, selected to minimize sample size in this exploratory study), assuming a mean baseline glycogen concentration of 283 μmol mlPrimary efficacy analyses were performed on the intent-to-treat population; safety analyses were performed on the as-treated population. All available data were included in the analyses and missing data were not imputed except as specified in the calculation of the AUC values. For the secondary and exploratory endpoints, only patients who could be evaluated with valid baseline or after baseline measurements were analysed. Changes from baseline were assessed using an ANCOVA model, with treatment group and baseline value as covariates. Separate models comparing cotadutide versus placebo and cotadutide versus liraglutide were generated; adjustments for multiple comparisons were not performed. Summary or descriptive statistics were generated for the analysis of clinical laboratory parameters and vital signs. For primary and secondary endpoints, the assumptions of each ANCOVA model were assessed and confirmed to be valid. Formal statistical testing for exploratory endpoints was not performed. Data analyses were performed using SAS v.9.3 or higher (SAS Institute) within a UNIX environment.