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SAMSON

Trial Details

Self-Assessment Method for Statin side-effects Or Nocebo

Design and Objective

Design: Double-blind, crossover, randomised controlled trial. Objectives: Develop a method for determining within an individual participant to what extent experienced symptoms are associated with the statin and to evaluate in a cohort of participants who have stopped statins because of adverse symptoms, in what proportion of them, the symptoms are truly due to the statin.

Key inclusion criteria

INCLUSION CRITERIA FOR MAIN TRIAL: • Previously taken one or more statins • Withdrawn from statins because of perceived side effects • Developed side effects within 2 weeks of initiation • Clinical indication for statins for primary or secondary prevention of cardiovascular disease or dyslipidaemia

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