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Overall responsibility for the design and implementation of the study was given to the National Institute of Child Health and Development, with input from a number of advisory and oversight committees, the Director of the NIH, and with the involvement of other government agencies (the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Environmental Protection Agency).
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These individuals together have extensive experience conducting large trials, are widely respected clinical scientists, had overcome considerable challenges in the implementation of the study, and had no stake in the outcome.
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Mr Brennan also raises concerns about other aspects of the government's plan, including "linear assessment for all subjects at the end of two years of study, the rushed timetable for implementation, and the limited evidence base on which the proposals have been made".
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