Reference no: EM133238629

A multicenter double-blind randomized study was carried out to compare the effect of drug X with that of a placebo in patients surviving acute myocardial infarction (AMI). Treatment with the drug started 7 days after infarction in 1,884 patients, 52% of all persons who were evaluated for entry into the study. 945 participants were randomized to treatment with drug X while 939 were assigned to the placebo group. Patients were then followed for 12 months for reinfarction. There were 152 deaths in the placebo group and 98 in the group receiving drug X.

After assignment to treatment group, 77% of those in the placebo group were men, while 80% of those in the drug X group were men. Which statement is most likely to be true?

1. Randomization was successful because there are more men in the treatment group.

2. Randomization failed since men are more likely to have a recurrent AMI in the drug X group.

3. Randomization failed because the researchers should have made sure that each group had an equal percentage of men.

4. Randomization was successful since the investigators did not alter the selection of participants in either group in order to ensure equal percentages of men.