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The primary trial endpoint was the rate of change of common carotid artery intima-media thickness (IMT).
The importance of trial design in terms of patient population and clinical trial endpoint has been demonstrated in these studies.
Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects).
Aggarwal C, Borghaei H. Treatment paradigms for advanced non-small cell lung cancer at academic medical centers: involvement in clinical trial endpoint design.
QoL, which is a particularly important trial endpoint if survival differences are unlikely may, however, be a more relevant outcome in the clinic.
To assess the suitability of severe malaria as a trial endpoint, we conducted a census in 1999 and measured the incidence of severe malaria from 1999 to 2001 in Bandiagara, Mali.
The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory.
The primary trial endpoint success criterion was achievement of >30 % reduction in mean target fibroid perfused volume in at least 50%% of patients at 3 months.
The evidence gained in this study provided support for the content validity of the PSS for use as clinical trial endpoint among patients with plaque psoriasis.
The null hypothesis for the primary trial endpoint at 3 months was H0: probability of success <50%% versus the alternative Ha: probability of success ≥50%%.
A core MRI facility was used to reduce variability and bias in MRI imaging quality, interpretation, and measurements relative to the primary trial endpoint.
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CEO of Professional Science Editing for Scientists @ prosciediting.com