Inclusion criteria are the guidelines that will identify if a subject can be included in a clinical drug trial. The person is usually required to be healthy or should have a specific medical condition that the trial drug is designed to treat. In comparison, exclusion criteria are guidelines that identify who will not be able to participate in the trial. This varies according to the drug being tested -- it can affect people who drink, smoke or exercise more than the average person, and it often affects people who have a complicated medical history. Exclusion criteria can also be based on race, age, gender and any health conditions that may be pre-existing.
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