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Analyses were conducted by visit, using an observed case approach, and included patients treated with olanzapine, risperidone or haloperidol who had a DAI-10 rating at baseline, after three months of treatment, and after 6 months of treatment.
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Exploratory secondary analyses will be performed using an observed cases approach.
We used an observed case approach with regards to missing data.
Data were summarised at each visit using an observed-case analysis and non-responder imputation (NRI).
Predicting full behavioral change after the intervention period ends, and thus substituting a missing endpoint, may increase uncertainty compared to using an observed outcome parameter like, in this case, smoking cessation.
While the predictive values appeared similar when calculated either using LOCF imputation or an observed case analysis, both ways may slightly bias the predicted response rates, and as such, general trends may be of more clinical value than precise figures.
Change from baseline in MADRS total score was analyzed using analysis of covariance using both observed case and last observation carried forward approaches.
The analyses will be based on a mixed-model-repeated-measurement (MMRM) analyses of change from baseline with the effect of the exposure variable interacting with the time point (month), using the observed cases and an unstructured variance-covariance matrix.
Descriptive analyses for efficacy were performed using both observed cases (OC) and baseline observation carried forward (BOCF) approaches.
Between-group differences within each stratum were calculated at 18 months for insulin sensitivity and inflammatory/thrombotic markers using ancova on observed case data at 18 months, adjusted for baseline value.
Sensitivity analysis to investigate the impact of the last observation carried forward (LOCF) imputation was performed using only observed cases.
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