Suggestions(2)
Exact(3)
If biomarker analyses are contemplated, then banked tumour samples may be used to perform prospective analyses prior to the primary trial analysis, potentially providing more robust data.
As mentioned above, studies have shown superior power compared to statistical testing using model-based E-R analyses as the primary trial analysis.
Three subpopulations were evaluated based on the dose response relationships established in the primary trial analysis: patients on the labeled dose of etoricoxib in RA (90 mg), those on other doses of etoricoxib (10-, 30-, and 60-mg groups combined for these analyses), and patients on placebo.
Similar(57)
For the primary trial efficacy analysis, the intention to treat population includes all participants who were randomized.
The primary ACUDep trial analysis showed a statistically significant reduction in PHQ-9 depression at three months for acupuncture (−2.5 score points, 95% CI: −3.7, -1.2) and counselling (−1.7 score points, 95% CI: −3.0, -0.5) compared to usual care.
The primary and secondary trial analysis will be conducted blind to intervention group by the statistician (EN) and an independent statistician will verify the analysis of the primary outcomes.
Two forms of economic evaluation will be undertaken for this project: (1) an incremental cost-effectiveness analysis based on primary trial data; (2) a net benefit analysis based on modelling a broader roll-out of this programme using data arising from this trial.
The randomised arms were conserved from the primary trial for the main analysis.
The primary trial protocol and the analysis plan are available in the online supplement.
A traditional "observed cases" (OC, the patients who completed the trial) analysis at 6 weeks was the primary efficacy analysis.
A traditional "observed cases" (OC, the patients who completed the trial) analysis in 42 days was the primary efficacy analysis.
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