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Due to the paucity of trials in people with PD using prospective falls as an outcome measure, the sample size calculation for the study was inherently speculative.
In the sample size calculation for the study we used a clinical difference of interest of two points on the 11-point numeric rate scale [ 13].
The sample size calculation for the study was based on the primary hypothesis: that those referred to group Art Therapy will have improved global functioning at 24 months compared to those referred to attention control treatment or standard care alone.
Thirdly, the power calculation for the study was based upon a mortality rate that far exceeded that observed in the study, thereby creating a significant chance of a type II error.
The original sample size calculation for the study, to detect a 28%% difference in neuropathy with a power of 80%%, was based on historical estimates on the incidence of neuropathy with the two treatments (incidence rates of CTCAE neuropathy events for eribulin [35%%] as per a previous Phase II study [ 12], and the package insert for ixabepilone [63 %]).
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Resulting image resolutions and MAE calculations (for the study of the sidelobe levels) are summarized in Table 2. Table 2 Results of resolution parameters and MAE for Cases 1 6.
The study lists Graves as a consultant who helped with calculations for the study, but Graves says he has deep concerns about the study.
SMP developed the statistical approach and conducted the power calculations for the study.
HW performed the calculations for the study, and helped with each version of the manuscript.
Table 1 shows power calculations for the study with alpha of 0.05 and beta of 0.20.
Since there are a large number of specific factors to be analysed, formal sample size calculations for the study as a whole were not feasible.
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CEO of Professional Science Editing for Scientists @ prosciediting.com