Marks: 1 True or False: You may not discuss any products or plan lines of business not agreed to in advance by the beneficiary. Another SOA would need to be obtained if the conversation were to lead to a discussion of another product or line of business (e. g, Prescription Drug Plan [PDP] vs. Medicare Advantage Prescription Drug [MAPD] Plan).

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