Exact(2)
7 We adapted this scale by removing three items pertaining exclusively to randomised trials (specifically, "blinding of study subjects to the intervention," "randomization to intervention groups," and "concealed randomized intervention assignment").
Was the randomized intervention assignment concealed from both patients and staff until recruitment was complete and irrevocable?
Similar(58)
GPs were asked to adhere to the randomized treatment assignment.
Methodological concerns of the studies included small sample size and concerns about randomized treatment assignment.
All analyses were based on the intention-to-treat (ITT) approach using the randomized treatment assignment.
All patients were combined in these analyses, regardless of randomized treatment assignment.
All subjects will complete baseline assessments prior to the randomized treatment assignment.
In the Losartan (vs. atenolol) Intervention For Endpoint reduction in hypertension (LIFE) study 10, multivariate analysis found every 10 bpm increase in RHR was associated with a 16% increased risk of CV mortality and 25% increased risk of all-cause mortality, independent of blood pressure lowering, randomized treatment assignment or other risk factors including left ventricular hypertrophy.
The intent-to-treat (ITT) Population (the primary efficacy analysis population) included any randomized patients with exposure to study drug (ferumoxytol or placebo) by randomized treatment assignment.
Statistical analyses were based on methods specified in an analytic plan completed prior to unblinding of the randomized treatment assignments.
The sponsor's study personnel (Medtronic) were not blinded to the randomized treatment assignments for individual subjects.
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