 1. Patient or parentlegal guardian is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of screening visit or during the conduct of the study. Subjects with prior diagnosis of co-morbid major psychiatric disorders i.e. aside from ADHD, including major depression, bipolar disease, Tourette syndrome, schizophrenia, autism spectrum disorder or pervasive development disorder, severe anxiety disorders 