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From 2 months postpartum to 12 months postpartum, carnitine and acetylcarnitine milk concentrations were lower, in the range of 6.1 to 8.9 mg/L for carnitine and 1.2 to 2 mg/L for acetylcarnitine.[6] Ten mothers of full-term infants and mothers of preterm infants (36 weeks gestation or less) provided blood and milk samples for measurement of carnitine at 4 times during the first month postpartum

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The applicant acknowledged that the device involved in this study was not the VersaVue TM Single-Use Flexible Cystoscope but asserted that this situation is identical to the Uretero1 TM transitional pass-through evaluation and approval