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Mandatory elements in the definition of an adverse event ( AE ) include which of the following? A . Untoward medical occurrence. B . Use

Mandatory elements in the definition of an adverse event (AE) include which of the following?
A. Untoward medical occurrence.
B. Use of pharmaceutical product or a study intervention.
C. Patient or clinical investigation subject involvement.
D. Causal relationship with the pharmaceutical product.
E. A, B, and C ealy.
F. All of the above.
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