Mean Phe concentration, μmol/L | Phe intake adjustment |
---|---|
At Week 2 | |
0–300 | Increase by 5 mg/kg/day |
301–359 | No adjustment required |
360–∞ | No adjustment required, but monitor concentration at next visit |
Post-Week 2 | |
0–180 | Increase by 15 mg/kg/day |
181–240 | Increase by 10 mg/kg/day |
241–300 | Increase by 5 mg/kg/day |
301–359 | No change in dietary Phe intake |
360–∞ | Determine if the subject had one or more previous dietary Phe intake increases • If so, remove the dietary Phe in the order that it was previously increased, beginning with the amount of the last increase • If not, no adjustment required |
360–1199 | If this is first occasion at this concentration, monitor concentration at the next visit and if second occasion is at this concentration, provide dietary counseling |
1200–∞ | If this is first occasion at this concentration, provide dietary counseling and monitor concentration at the next visit and if second occasion is at this concentration, provide dietary counseling and terminate from the trial |