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This may have rendered possible differences over 6 weeks between groups difficult to detect.
Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle.
The difference in the change in HbA1c concentrations from baseline to 24 weeks between groups in favour of liraglutide was −12.4 mmol/mol (95% confidence interval −16.0 to −8.8 and −1.14%, −1.47 to −0.80; P<0.001).
For outcomes measured on a continuous scale, differences in mean change from baseline to 12 weeks between groups will be evaluated using linear regression modelling while adjusting for baseline levels of the outcome measure.
To determine the effects of age, perlecan deficiency, and diabetes on the LCS measurement outputs, unpaired two-sided Student's t-tests were performed between groups 1 and 2 (15 weeks vs. 32 weeks), between groups 3 and 2 (perlecan-deficient bones vs. WT), and between groups 4 and 5 (diabetic bones vs. WT), respectively.
The primary analysis was a comparison of stratum corneum hydration score on the buttocks at 4 weeks between groups adjusted for the corresponding initial score using analysis of covariance, with the stratification variable (family history of atopic eczema) included as a factor.
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Although this outcome did not reach the established limit for statistical significance at 12 weeks, between-group differences should be considered clinically significant.
At 3 years, glycemic control was still comparable for EXE and GLAR treatment: the HbA1c values were 6.6 ± 0.2%, and 6.9 ± 0.2% at 168 weeks (between-group difference: P = 0.186) (Fig. 2 A ).
ADAS-cog scores showed an increase over time in both study groups, indicating cognitive decline, without significant differences between the active and control group over 24 weeks (between-group difference of 0.37 points, standard error = 0.57, P = 0.513, mixed models for repeated measures).
At both 4 and 8-weeks, between-group differences were noted for both HAD depression and HAD anxiety (Table 3).
Statistically significant differences were found at 12 and 24 weeks between group A and group B. At different time points, the scores in group A were higher than group B (* P < 0.05).
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