Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.

中文翻译：

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移植人群CMV疾病治疗和预防的治疗学发展：监管观点

巨细胞病毒（CMV）仍然是移植人群中的重要病原体。因此，美国食品和药物管理局（FDA）已发布指南，以鼓励和告知开发用于治疗和预防该人群CMV疾病的疗法。这篇综述总结了行业中重要的第3阶段试验设计注意事项，并为指南中包含的一些建议提供了依据。