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Clinical trial design and optimization Clinical trials require dose escalation studies to establish acute and long-term toxicity, dose-limiting toxicity, the maximum tolerated dose, and to outperform standard-of-care regimens

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4,6,7 Opioid replacement therapy not only mitigates these changes in neurotransmitters but is also associated with apoptosis, white and grey matter injury, altered redox homeostasis, and changes in oligodendroglial maturation and myelination, which may be particularly damaging in the developing brain