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Footnotes Related to Table 6-1:
Patients completing the ¡°Abbreviated Visit Schedule¡± should omit those assessments shaded grey in Table 6-1.
Patients in the Open-label treatment epoch should complete the same visits and assessments as in the Double-blind treatment epoch. The visits in the Open-Label epoch will be numbered using the 401-499 range, with visit number 499 being the Open-label end of treatment visit.
Patients undergoing the blinded dose reduction will perform an additional visit 1 week after dosage change. Lab samples and pop PK samples will be taken at this ¡®post-dose switch¡¯ visit.
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