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Three important issues are always addressed by the primary statistical analysis of confirmatory clinical trials.
Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph.
Primary statistical analysis of the efficacy endpoint was performed 6 months after registration of the last patient for the study.
The primary statistical analysis of efficacy data is based on the intention-to-treat patients, who were randomly assigned to treatment and received at least one dose of medication.
Primary statistical analysis of the pooled data (mean±standard deviations) was performed with the analysis of variance (ANOVA) to determine mean differences in objective measurements of parotid gland tumour groups by helical CT, followed by Student-Newman-Keuls – q (SNK-q) test for multiple comparisons.
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Primary statistical analysis consisted of estimation of the complete and partial response rates.
The primary statistical analysis was the testing of the effect of pioglitazone in comparison to metformin and the combination of both on a possible change of MMP-9 after a 6-month treatment compared to baseline.
The primary statistical analysis was the comparison of the difference in change in markers of kidney injury between the n-3 PUFA supplementation period and placebo period.
Comparison between treatment arms of the crude proportions of patients with ulcers at 24 weeks with a Cochran Mantel–Haenszel test stratified by the two randomization risk factor strata (use of low-dose aspirin and other anticoagulants, prior ulcer history) was specified as the primary statistical analysis at the time of sample size calculation and study initiation.
The primary statistical analysis used a repeated-measures analysis of variance (rmANOVA) with BP ND as dependent variable, diagnosis (tic or control) as a between-group variable, time (before or during the infusion) and day (placebo or levodopa) as within-subject variables, and region (the six VOI-based BP NDs) as a repeated measure.
HL performed the primary statistical analysis, and wrote the bulk of the paper.
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CEO of Professional Science Editing for Scientists @ prosciediting.com