What are some important questions that should be asked of the patient?

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In a study of a weight loss program, 40 subjects lost a mean of 3.0 lb after 12 months. does the weight loss program have practical significance? a. yes, because the weight loss program worked and the subjects lost a mean of 3.0 lb. b. no, because the mean weight loss of 3.0 lb after one year does not seem to justify the program. c. no, because the sample of 40 subjects was too small to determine if the program was useful. d. yes, because the mean weight loss of 3.0 lb after one year does seems to justify the program.

Adouble-blinded trial for a new indication is conducted under an ind comparing two (2) marketed drugs, at twice the approved prescribed doses. on day 2, subject 603 had difficulty breathing. although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. on day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. these episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. the investigator would submit an sae report for