Suppose in the actual study that 200 participants are randomized to each group. Forty-four participants who receive

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Suppose in the actual study that 200 participants are randomized to each group. Forty-four participants who receive drug A and 35 participants who receive current therapy die of CVD in the next 5 years. Can the treatments be considered equivalent? Why or why not? 


Hypertension

A drug company proposes to introduce a new antihypertensive agent that is aimed at elderly hypertensive participants with prior heart disease. Because this is a high-risk group, the company is hesitant to withhold antihypertensive therapy from these patients and instead proposes an equivalence study comparing the new agent (drug A) with the current antihypertensive therapy used by those participants. Hence, the participants will be randomized to either maintenance of their current therapy or replacement of their current therapy with drug A. Suppose the endpoint is total cardiovascular disease (CVD) mortality, and it is assumed that under their current therapy 15% of participants will die of CVD over the next 5 years.

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