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To achieve a therapeutic breakthrough in TBI, multifaceted approaches are probably required, including the development of new clinically relevant models, refinements of established models and functional tests, consideration of systemic insults and multimodality monitoring, identification of specific and sensitive biomarkers, and optimization of therapeutic dosing and timing of single and combination treatments, as well as improvement in clinical trial design and operation

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prior FDA approval for pediatric GHD Limited Small Phase I/II trials only Minimal Primarily animal studies

Avoid injecting the water directly and forcefully onto the lyophilized cake itself