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For the economic analysis, the same primary outcomes that have been considered in the statistical analysis will be used.
A further publication from the group examined the role of maternal BMI with the same primary outcomes [ 4].
Among the five olanzapine trials, four trials retrieved were designed with similar selection criteria – AD with psychosis, 6-week to 12-week treatment durations – and the same primary outcomes – that is, BPRS and NPI.
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In contrast, a second, similarly designed phase 3 study found that adjunctive armodafinil 150 mg/day provided numerically, but not statistically significantly, greater improvement in bipolar I depression than placebo on the same primary outcome (Ketter et al., 2015).
The same primary outcome was used in a trial comparing rabeprazole vs. placebo in GERD patients without erosive or ulcerated esophagitis on endoscopy [ 13].
Estimates of a clinically relevant effect size were derived from the Göttingen pilot-study using the same primary outcome measures [ 18].
In a previous report comparing saline and clonidine pretreatment in the prevention of bupivacaine-induced cardiotoxicity in rats, the investigators used the same primary outcome that was used in this study [ 9].
Moreover, although it has been suggested that delta should be based on an assessment of the MCID, our finding of wide variation in predicted deltas in studies with the same primary outcome demonstrates that this is not happening [ 29- 31].
Follow up measurements were performed by sending questionnaires to participating patients 1, 3, 6 and 12 months after the last injection and consisted of the same primary outcome measures as during short term assessment except for direct treatment response.
Estimates used in the sample size calculation were taken from the FAB study, which had a similar sample population and the same primary outcome to that proposed here (i.e., PAEE) [ 91].
The following power analysis is based on a previous study by Safren et al. [ 24] which compared CBT plus continued medication with continued medication only in ADHD and used the same primary outcome symptom measure as will be used in the current study.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com