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The aim of this paper is to evaluate the history, utility, and clinical efficacy of renal artery denervation technology, including an in-depth appraisal of the current literature and principal trials.
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Such elements include the measurement of relevant clinical outcomes, definition of endpoints, effect sizes, multiple inferences, and principal trial design choices such as placebo- or active-controlled trials.
"The trial divisions of the Superior Court are the principal trial courts of New Jersey.
Zamora, a public defender for three decades, was the office's principal trial attorney before she retired in 2007 and went into private practice.
The principal trial used to provide evidence of clinical effectiveness in delayed union was Schofer et al.
The lead investigator identified clinical diagnoses in consultation with the principal trial investigator ± the local safety monitor.
Those patients will be excluded from the principal trial but will continue in the 'comprehensive cohort study' of recruited patients.
TP, principal investigator; AP, investigator; EMcC, investigator; PS, statistical, support; BS, statistical support; AT, principal data manager; SA, principal trial statistician; IS, investigator; LO, investigator; JK, investigator.
Given the challenges of recruiting participants and implementing interventions in a population with a high burden of illness, the success of our pilot was a necessary precursor to a principal trial that examines patient-relevant clinical outcomes.
Over the course of the scoping exercise we formally interviewed 25 individuals on a one-to-one basis including: nine potential trial participants; six representatives from patient interest /support groups; nine researchers (including trial principal investigators, trial managers and a research nurse); and one pharmaceutical/medical devices industry representative.
This proof-of-principal trial used surrogate biological endpoints (proliferation and apoptosis) in patients with atypical breast lesions to test the efficacy of IGF-I inhibition.
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