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Theres no official update yet on US approval or an FDA submission

Levy PD, Willock RJ, Burla M, Brody A, Mahn J, Marinica A, et al

382 Currently, rodents and nonhuman primates, such as chimpanzees, are accepted models for identifying social behavioural changes in autism

The presentation of primary carnitine deficiency is quite variable with respect to the age of onset, the severity of the symptoms, and the involved organs