A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels

Exclusion Criteria

• •Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
• •Withdrew from, or otherwise did not successfully complete, study PKU-003, except for subjects who were removed from the study because their blood Phe exceeded the alert level
• •Expected to require any investigational agent or vaccine prior to completion of all scheduled study assessments
• •Pregnant or breastfeeding, or planning pregnancy
• •Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
• •Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
• •Concurrent use of levodopa