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Question: 1. Describe the phases for testing new drugs in the United States. Why does it take so long for a new drug to come to market in the U.S.? Your response must be at least 200 words in length.

2. Describe the important elements of randomized trials, explaining why each element is necessary for a successful study. Your response must be at least 200 words in length.

3. Explain five different ways of describing the natural history of disease. Briefly explain why each approach might be utilized. Your response must be at least 200 words in length.

4. Discuss sample sizes, Type I Errors, Type II Errors, power, generalizability, and internal validity. Provide an example for each of these. Your response must be at least 200 words in length.

Gordis, L. (2014). Epidemiology (5th ed.). Philadelphia, PA: Saunders.

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