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Practical considerations related to the use of particular methods in planning analyses are presented.
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Planned analyses are in full compliance with the principles of the Declaration of Helsinki.
Since our planned analyses are primarily analysis of covariance, we calculated the power of a two-sample t-test.
Since our planned analyses are primarily analyses of covariance with baseline as the covariate, we calculate the power of a two-sample t-test on change scores from baseline to 4 months.
While pharmaceutical company personnel are actively engaging investigators during the course of the trial, once planned analyses are completed and the final result reported, these resources often disperse to support different internal efforts.
A summary of the planned analyses is listed below.
All planned analyses were descriptive with no hypothesis testing.
Planned analyses were carried out on data at 3 and 6 months, in comparison with baseline.
A major strength of the planned analyses is the register-based outcome with a specific diagnosis.
Planned analyses were conducted to address the study objectives as defined, using a nominal significance level of 0.05.
Planned data analyses are in full conformance with the principles of the 'Declaration of Helsinki'.
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