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Cauley JA, Gutai JP, Kuller LH, Dai WS Usefulness of sex steroid hormone levels in predicting coronary artery disease in men. Am J Cardiol. 1987 Oct 1;60(10):771-7.
Cohen JD, Neaton JD, Prineas RJ, Daniels KA Diuretics, serum potassium and ventricular arrhythmias in the Multiple Risk Factor Intervention Trial. Am J Cardiol. 1987 Sep 1;60(7):548-54.
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Coughlin SS, Neaton JD, Sengupta A Cigarette smoking as a predictor of death from prostate cancer in 348,874 men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 1996 May 15;143(10):1002-6.
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Grimm RH Jr, Neaton JD, Ludwig W Prognostic importance of the white blood cell count for coronary, cancer, and all-cause mortality. JAMA. 1985 Oct 11;254(14):1932-7.
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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.