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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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Asoccer mom is driving her 75 year old grandmother and her 9 year old daughter home after the game. the grandmother and daughter were both in the back seat and both were wearing their seat belts. a car ran a red light in front of them, causing them to t-bone that car on the passenger side. fortunately there were no serious injuries, but the grandmother did sustain several rib fractures. the mother, daughter and driver of the at-fault car were shaken up but unhurt. what are some possible reasons that the grandmother sustained rib fractures while the other victims did not?