You are designing a trial to compare two drugs for treating heart disease; this trial will use a composite endpoint.

You are designing a trial to compare two drugs for treating heart disease; this trial will use a composite endpoint. You need to choose between two possible composite endpoints: (A) first occurrence of heart attack or cardiac death, or (B) first occurrence of heart attack or death from any cause.

a.) Give an example of an event that is included in composite (B) but not included in composite (A).

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b.) When we analyze the data from this trial, we will count up the number of persons who experienced the endpoint. (A larger number of persons with the endpoint usually means larger statistical power for testing the treatment effect.) Do we expect composite (A) or composite (B) to have a larger count of people who experienced the endpoint? Justify your answer.

c.) However, recall the example event that you gave in part 1. Is there likely to be a treatment group difference for that type of event? Explain your answer.

d.) Therefore, which composite do you recommend? Justify your answer.

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