Sample size justification and planned data analysis strategy
obesity
OBESITY
Assuming as analysis method a RM-ANOVA with the within-subject variable time (before and after intervention [baseline, week 8]) and the between-group variable group (“add-on Celecoxib” versus “add-on placebo”) with A statistical analysis plan will be developed before any analyses will be performed. For the primary endpoint analysis, a linear mixed model non-restrictively assuming an unstructured covariance matrix will be performed with fixed factors group, time and ‘group x time’ interactions. Analyses will be adjusted for centre, BMI, age and gender as obesity, age and gender may impact cytokine levels. Moreoever, an adjustment of those analyses for PANSS total baseline scores in the case of significant group differences will be performed. Baseline differences will be analyses with independent The primary economic evaluation (add-on study) will be in the form of a within-trial incremental cost–utility analysis appended with further cost-effectiveness analyses conducted both from a health and social care perspective and from a societal perspective (Drummond et al. 