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Protocol

Introduction

The therapy

The n-3 PUFA hypothesis

The statins hypothesis

Study design

Primary objectives

Other end-point measures of efficacy

Subgroup analysis

Mechanistic goals

Concomitant treatments

Sample size calculation

Main analyses

References
  Other end-point measures of efficacy


To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:

Cardiovascular mortality,
Cardiovascular mortality or hospitalizations for heart failure or for any reason
Sudden cardiac death
Hospitalizations for any reason
Hospitalizations for cardiovascular reasons
Hospitalizations for congestive heart failure
Myocardial infarction
Stroke