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Hu, W., Bielawski, J., Samad, F., Merrill, A

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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)