The customer wanted to expand enrollment and revise the study from a Phase II study with 180 patients in Protocol Amendment 2 to a Phase IIb registration study with 564 patients in Protocol Amendment 3. Due to the timing of Amendment 3 finalization just prior to planned enrollment close under Amendment 2 and the increasingly rapid enrollment, the Syneos Health™ team developed an action plan to ensure that enrollment was seamless between the two amendments.


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