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Mandatory elements in the definition of an adverse event (AE)...

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 only 

F. All of the above.

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