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Associations between baseline parameters will be examined.
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Change from baseline in lipid parameters will be analyzed using ANCOVA.
Baseline assessments and outcome parameters will be summarized.
Baseline assessments and outcome parameters will be summarized using simple descriptive statistics.
Mean changes from baseline in safety laboratory parameters will be compared between treatment groups using a one-way ANOVA.
For all of these covariables, the correlation coefficients for their changes from baseline vs. the HbA1c parameters will be computed, too.
The baseline net ecosystem C balance parameters will be used as a reference scenario in the LUCAS model for further collaboration with the GDSNWR.
Baseline values for CIMT and efficacy laboratory parameters will be compared between treatment groups using a two-way ANOVA with effects for baseline atorvastatin dose and treatment group.
Anthropometric parameters will be measured at baseline, 8 weeks and at 3 months.
Efficacy parameters will be assessed at baseline and at the planned follow-up visits at 6 weeks, 3 months and 6 months after the injection.
All parameters will be assessed at baseline (t0), after six months (t1), and after 12 months (t2) from all patients receiving the intervention and from all controls.
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