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doi: 10.1016/S0169-4758(00)01788-9 28 StadeckerMJAsahiHFingerEHernandezHJRutitzkyLISunJ

2 The approval was based on adequate bridging between the oral granule and approved capsule formulations in a relative bioavailability study in healthy adults (Study 89) and exposure matching between the pediatric patient populations in the SPRINT phase 2 Stratum 1 study (NCT01362803) and the SPRINKLE study (NCT05309668)

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Do not exceed the recommended dosage.