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Differences between values after 12-week intervention were analyzed in Stata 9.2 (Stata ™, Texas) using a mixed model analysis of covariance with treatment (lignan or placebo) and period (first or second period) as fixed factors, subjects as random factors, and baseline measurements as covariates.
Inter-subject variability in baseline hemodynamic measurements was controlled for by considering baseline measurements as covariates.
Moreover, using the analysis of covariance model the difference between groups was compared for all parameters at each time point controlling for baseline difference using the value of parameter at each time point as the dependent variable and baseline measurements as covariates.
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Models were constructed with the follow-up measurements as dependent variable and the baseline measurement as covariate.
The primary endpoint will be analysed using a mixed model with time, treatment, time × treatment interaction as fixed effects, baseline measurement as covariate, and patient as random effect.
Dietary habit and physical exercise questionnaire data analysis was performed using the GLM model, with treatment as study variable and baseline measurement as covariate.
Comparison across groups was carried out by analysis of covariance (ANCOVA) with the follow-up measurement as dependent variable, the randomized agent as factor, and the baseline measurement as covariate (or as categorical co-factor in case of NYHA class).
A linear fixed-effects model was used to assess the difference between the lixisenatide and liraglutide groups for change from baseline in corrected glucose AUC0 30 4 30h determined on day 28, with fixed terms for treatment and study site and with the baseline measurement as covariate.
We will use linear mixed models to analyze all outcome variables (i.e. psychological distress, quality of life (only for patient), caregiver appraisal (only for partner), relationship quality and spirituality), with treatment as fixed factor, baseline measurement as covariate and a random intercept based on MBSR group.
Repeated measures ANOVA with baseline measurements as a covariate and 3, 6 and 12 months as outcomes revealed no group (LI versus UC) effects for QOL outcomes (Table 2).
Between group efficacy analyses were performed using analysis of covariance (ANCOVA) using change from baseline as the dependent variable and baseline measurements as the covariate.
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