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Protocol

Introduction

The therapy

The n-3 PUFA hypothesis

The statin hypothesis

Study design

Primary objectives

Other end-point measures of efficacy

Subgroup analysis

Mechanistic goals

Concomitant treatments

Sample size calculation

Main analyses

References
  Primary objectives


The study aims to demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:

All-cause mortality

All-cause mortality or hospitalizations for cardiovascular reasons