Describe how you would design a valid randomized controlled trial to test the hypothesis that Low-Chol, a new oral medication to lower serum

Describe how you would design a valid randomized controlled trial to test the hypothesis that Low-Chol, a new oral medication to lower serum cholesterol, decreases the risk of death from coronary heart disease in healthy men, 40-54 years of age, at high risk for the disease. Include in your description how you would select the study sample, determine the subject eligibility criteria, ascertain the appropriate sample size, allocate the subjects into experimental and control groups, apply the intervention, and assess the outcomes during follow-up.