Table 2 Inclusion criteria for patient participation in the Extension Study

1. Completed visit 6 of the Parent Study

2. The principal investigator determines further treatment with IB1001 to be in patient’s best interest

3. Written informed consent signed by the patient and/or their legal representative/parent/impartial witness for participation in the Extension Phase

4. Patients are willing to continue to remain without the following prohibited medication from visit 6 throughout the duration the Extension Phase:

 e) N-acetyl-DL-leucine (e.g., Tanganil®);

 f) N-acetyl-L-leucine (prohibited if not provided as investigational medicinal product [IMP]);

 g) Sulfasalazine;

 h) Rosuvastatin