A Large-Scale Clinical Trial Is Being Planned to Evaluate the Effect

A large-scale clinical trial is being planned to evaluate the effect of a nonselective beta blocker, propranolol, on the clinical course of portal hypertension.  The comparison is with placebo.  The primary outcomes of the study are all-cause mortality and major gastrointestinal hemorrhage.  Secondary outcomes are minor gastrointestinal hemorrhage and the number of hospitalizations.  Classification of the episodes of gastrointestinal hemorrhage into "major" and "minor" is based on clinical assessment as well as laboratory data such as change in hemoglobin level.  The investigators are concerned about the possibility that major gastrointestinal hemorrhage events could be over-reported in the placebo group.  Which of the following is the most useful technique to reduce this possibility?

A) Blinding
B) Matching
C) Randomization
D) Restriction
E) Stratified analysis

Correct Answer:

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