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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
  Concomitant treatments


All treatments proven to be effective for the treatment of congestive heart failure will be positively recommended (specifically ACE-inhibitors, betablockers, diuretics, digitalis, spironolactone).

Patients can be treated with amiodarone, aspirin and/or oral anticoagulants according to the clinical decision of attending investigators.

Open label n-3 PUFA or lipid lowering drugs are not permitted for patients in the R1 or R2 component of the trial, unless a specific clinical indication for treatment according to the Investigator judgment emerges during the course of the study.