The Physicians' Health Study was a randomized, double-blind, placebo-controlled trial of 22,071 apparently healthy male physicians. Subjects were randomized into two groups: one group took a buffered aspirin every other day and the other was given a placebo. The average follow-up during the aspirin component of the trial was 60.2 months. Baseline cardiovascular risk factors and adherence to therapy during the trial were assessed by questionnaire. Cardiovascular outcomes were reported by questionnaire and confirmed by record review by an Endpoints Committee. Among those taking the aspirin, 104 heart attacks (with five deaths) occurred compared to 189 heart attacks 18 of them fatal among those taking the placebo. The study was terminated early, due principally to a 44% reduction in the risk of a first myocardial infarction (MI). Which of the following are NOT a reason(s) to use a placebo in this trial? Select all that apply. To ensure the ethical review board will approve the study Improves the comparability of compliance and follow-up in the groups To reduce costs in a trial To make sure observed improvements in the outcome are not due to effects other than the treatment
The Physicians' Health Study was a randomized, double-blind, placebo-controlled trial of 22,071 apparently healthy male physicians. Subjects were randomized into two groups: one group took a buffered aspirin every other day and the other was given a placebo. The average follow-up during the aspirin component of the trial was 60.2 months. Baseline cardiovascular risk factors and adherence to therapy during the trial were assessed by questionnaire. Cardiovascular outcomes were reported by questionnaire and confirmed by record review by an Endpoints Committee. Among those taking the aspirin, 104 heart attacks (with five deaths) occurred compared to 189 heart attacks 18 of them fatal among those taking the placebo. The study was terminated early, due principally to a 44% reduction in the risk of a first myocardial infarction (MI).
Which of the following are NOT a reason(s) to use a placebo in this trial? Select all that apply.
To ensure the ethical review board will approve the study
Improves the comparability of compliance and follow-up in the groups
To reduce costs in a trial
To make sure observed improvements in the outcome are not due to effects other than the treatment
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