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Volumn 6, Issue 4, 2009, Pages 305-319

Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thickness

Author keywords

[No Author keywords available]

Indexed keywords

ANTILIPEMIC AGENT; ATORVASTATIN; CHOLESTEROL ESTER TRANSFER PROTEIN INHIBITOR; EZETIMIBE PLUS SIMVASTATIN; NICOTINIC ACID; PLACEBO; ROSUVASTATIN; SIMVASTATIN; TORCETRAPIB;

EID: 70449653301     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509339977     Document Type: Article
Times cited : (11)

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