An Open Label Study of CM-AT for the Treatment of Children With Autism

Inclusion Criteria:

• Age between 3 and 8 years, inclusive, at the time of signing informed consent/assentin Sponsor 00103 Study

• Completion of the Sponsor's 00103 Study who continue to meet eligibilityrequirements

• Currently in the 00102 open label study and continue to meet eligibilityrequirements

• Subjects who initially qualified for 00103 screening, who subsequently failedBaseline entrance criteria for randomization (@Visit 1) Baseline assessment of theABC eligibility requirement who continue to meet eligibility requirements

• Up to 20 subjects 9-17 years of age who directly enroll into this study, who meetthe current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR)diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed bythe ADI-R

Exclusion Criteria:

• Patient weighing < 13kg

• Allergy to porcine products

• Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase

• History of severe head trauma, as defined by loss of consciousness orhospitalization, skull fracture or stroke.

• Seizure within the last year prior to enrollment, or the need for seizuremedications either at present or in the past.

• Evidence or history of severe, moderate or uncontrolled systemic disease

• Ongoing dietary restriction for allergy or other reasons except nut allergies.Lactose free is allowable but not dairy free.

• Inability to ingest the study drug / non-compliance with dosing schedule.

• Inability to follow the prescribed dosing schedule.

• Use of any stimulant or non-stimulant medication or medications given for attentiondeficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to theinitial randomized study period.

• Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stabledose for a minimum of 30 days prior to entering the study.

• History of premature birth <35 weeks gestation.

• Prior history of stroke in utero or other in utero insult.