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The FDA provides this statement without including references as to how the calculations were made, and of which, as we will show below, the FDA have not provided such risk assessments

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What About "Clinical Trials" and "Expanded Access"

She conducts clinical trials examining the feasibility, safety and efficacy of ketogenic therapies in managing patients with medically resistant epilepsy and refractory status epilepticus, and also collaborates with investigators to evaluate these treatments for patients with alcohol withdrawal, glioma, migraine, multiple sclerosis, dementia, psychiatric disorders and obesity hypoventilation syndrome

Informed consent was obtained from all participants, and all methods were performed in accordance with the relevant guidelines and regulations