The human microbiome: our second genome
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National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Board on Health Sciences Policy, Committee on Accelerating Progress in Traumatic Brain Injury Research and Care, Matney C, et al
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No robust pediatric or adolescent data are available to date
Regulatory agencies like the FDA require strong safety databases for drugs that will be prescribed to millions of people, and a trial of this size provides the statistical power needed to detect both efficacy signals and uncommon adverse events