Emilie is happy that she is pregnant. which immediate change in her lifestyle is required? a)stop night outs with friends b)try to improve relations with her mom c)stop drinking alcohol d)stop working

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: a. neither of the subjects b. subject 603 only c. subject 20 only d. both of the subjects

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Which of the following statements is true?