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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
  Main analyses


The following analyses will be performed on:

the R1 phase to test for the treatment difference between n-3 PUFA and placebo on the two primary endpoints.

the R2 phase to test for the treatment difference between rosuvastatin and placebo on the two primary endpoints

The main analysis will be performed according to an intention-to-treat approach, therefore all patients randomised in the study will be included in the analysis.
Baseline characteristics will be presented by treatment groups. Any unbalance for baseline characteristics thought to be of prognostic importance will be considered for multivariate adjustment in the subsequent analyses.
Plots of the Kaplan-Meier estimates of the survival curves will be presented.
A Cox proportional hazards model with terms for fish-oil, rosuvastatin and their interaction will be fitted to the data. If the term for interaction is non significant, it will be removed from the model. Results will be presented in terms of hazards ratios.