AusPAR Attachment 2: Extract from the Clinical Evaluation ...
Doses of 1,197 mg/day and 2,403 mg/day were chosen for Study PIPF-004 and 2,403 mg/day for Study PIPF006 and Study PIPF016. The 2,403 mg dose was considered to be that needed to achieve efficacy based on previous clinical experience, and the 1,197 mg dose was included for additional qualitative safety and efficacy information. ................
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