Effectiveness of the investigational drug

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Problem 1:

Suppose we ignore the order in which the patients received the treatments. Count the number of patients who had higher sleep duration on the investigational drug than on placebo.

a. Suggest another simple test for assessing the effectiveness of the investigational drug.

b. Give a p-value for the test of part (a).

Problem 2:

An investigational drug product was studied under sleep laboratory conditions to determine its effect on duration of sleep. A group of 16 patients willing to participate in the study were randomly assigned to one of two drug sequences; 8 were to receive the investigational drug in period 1 and an identical-appearing placebo in period 2, and the remaining 8 patients were to receive the treatment in the reverse order.

a. Identify the design.

b. Give a model for this design.

c. State the assumptions that might affect the appropriateness of this design.

Reference no: EM131029296

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