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Mean (SD) change in the CGI-BP-S and CGI-S scores were reported from the baseline of the original double-blind acute treatment study based on both an observed case (OC) and last observation carried forward to endpoint (LOCF-endpoint) analysis.
We used an observed case approach with regards to missing data.
The complete data of an observed case could be seen by the investigator group only after the matching in the study database.
It was concluded therefore that an imputation strategy was inappropriate and an observed case analysis was considered to be the most useful way of analysing the data.
The proportion of patients rated as improved (somewhat improved, moderately improved, or very much improved) was calculated using the "intention-to-treat" approach in an "observed case" manner (i.e., no imputations were made for missing data).
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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Analysis was conducted using three possible datasets: (i) imputation of missing values according to the last observation carried forward (LOCF) methodology; (ii) an observed cases methodology (that is, the absence of data imputation); and (iii) considering patients with missing data as nonresponders.
We performed an observed cases analysis for the first two weeks of treatment.
Exploratory secondary analyses will be performed using an observed cases approach.
SIGH-SAD scores were analyzed in both a last observation carried forward (LOCF) analysis, including all 26 participants who were randomized, and an observed cases (OC) analysis, including all 23 participants who completed the trial.
At trial end, the proportions of participants in remission (SIGH-SAD less than 9) were significantly greater (Fisher's exact test), and SIGH-SAD scores, as percent individual score at randomization, were significantly lower (t-test), with active treatment than with control, both in an intent-to-treat analysis and an observed cases analysis.
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