Which one of the following is a primary objective of a Phase III study of...

Phase III clinical trials primarily aim to demonstrate or confirm the therapeutic benefit of a new investigational product (IP) compared to standard treatments or placebo. These trials are typically larger and are designed to provide robust evidence of efficacy and further evaluate safety.

According to GCP guidelines, Phase III trials focus on confirming the therapeutic efficacy of the IP in a larger population.

"Phase III trials aim to confirm the therapeutic benefit and safety of the investigational product compared to existing treatments."

Objectives:

Confirm therapeutic efficacy.

Provide comprehensive safety data.