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In a long-term open-label epilepsy study in pediatric patients 1 to 24 months old, 7% developed kidney or bladder stones

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Patients were randomly assigned into two arms, patients in one of the arms received biopsies between the 3 rd and 10 th day following the start of the treatment (referred to as the "early immune response") and another arm received biopsies at the thirty-day mark (referred to as the "late immune response")