When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children.

Comparing the combined intervention arms against control (a secondary comparison) gave a highly significant result ( P = 0.004), although it had not crossed the implicit threshold ( P = 0.002) for proven benefit that was set at the beginning of the study.

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