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Updated: Aug 17, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[Statistical notes. Randomized controlled clinical trials of both superiority and non-inferiority: critical
Ettore Marubini1, Paola Rebora, Giuseppe Reina
1Istituto di Statistica Medica e Biometria, Università degli Studi, Milano. ettore.marubini@unimi.it
Abstract:
The aim of this statistical note, the fourth in the series, is to describe and critically appraise the randomized controlled clinical trial (RCCT) GUSTO V, which combined in a single RCCT both the superiority and non-inferiority hypotheses. In this note we present the logical path that the authors have presumably followed in planning a RCCT of such a kind. The results are reported and possible critical aspects are highlighted and debated upon. Finally the cardiologist reader is stimulated to give his own opinion on this kind of approach.
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