Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe

Inclusion Criteria:

1. Subjects where Study SPD503-318 was not available at the time of their final visit inthe antecedent study (SPD503-315 or SPD503-316), may still be screened unless they arewell-controlled on another ADHD medication with acceptable tolerability and theparent/caregiver is satisfied with their current ADHD medication.
2. Subject satisfied all entry criteria for the antecedent study (SPD503 315 orSPD503-316).
3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of ageor <9 years of age and is post-menarchal, must have a negative serum beta humanchorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and anegative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply withany applicable contraceptive requirements of the protocol.
4. Subject's parent or legally authorised representative (LAR) must provide signature ofinformed consent, and there must be documentation of assent (if applicable) by thesubject indicating that the subject is aware of the investigational nature of thestudy and the required procedures and restrictions in accordance with theInternational Conference on Harmonisation (ICH) Good Clinical Practice (GCP) GuidelineE6 and applicable regulations, before completing any study-related procedures.
5. Subject and parent/LAR are willing, able, and likely to fully comply with all thetesting and requirements defined in this protocol, including oversight of dosing.Specifically, the parent/LAR must be available upon awakening, to dispense the dose ofinvestigational product for the duration of the study.
6. Subject has a supine and standing blood pressure (BP) measurement within the 95thpercentile for age, sex, and height.
7. Subject is functioning at an age-appropriate level intellectually, as deemed by theInvestigator.
8. Subject is able to swallow intact tablets.

Exclusion Criteria:

1. Subject has any current, controlled (requiring a prohibited medication or behaviouralmodification program) or uncontrolled, co-morbid psychiatric diagnosis (exceptoppositional defiant disorder), including any severe comorbid Axis II disorders orsevere Axis I disorders such as post traumatic stress disorder, bipolar illness,psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substanceabuse disorder, or other symptomatic manifestations or lifetime history of bipolarillness, psychosis or conduct disorder that, in the opinion of the Investigator,contraindicate treatment with SPD503 or confound efficacy or safety assessments. TheKiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetimeversion (K-SADS-PL) rating from the antecedent study should be reviewed to confirmdiagnosis, if necessary.
2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocolnon-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject.
3. Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would precludeexposure to SPD503.
4. Clinically important abnormality on urine drug and/or alcohol screen at the ScreeningVisit (Visit 1).
5. Subject has taken any investigational product as follows: last dose of investigationalproduct in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2);investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the BaselineVisit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2).
6. Subject is significantly overweight based on Center for Disease Control and PreventionBody Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1).Significantly overweight is defined as a BMI >95th percentile.
7. Children aged 6 12 years with a body weight of less than 25.0kg or adolescents aged 13years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1).
8. Subject has any condition or illness including clinically significant abnormallaboratory values at the Screening Visit (Visit 1) which, in the opinion of theInvestigator, represents an inappropriate risk to the subject and/or could confoundthe interpretation of the study.
9. Subject is currently considered a suicide risk in the opinion of the Investigator, haspreviously made a suicide attempt, or has a prior history of, or is currentlydemonstrating active suicidal ideation. Subjects with intermittent passive suicidalideation are not necessarily excluded based on the assessment of the Investigator.
10. Subject has clinically significant ECG findings, as judged by the Investigator withconsideration of the central ECG laboratory's interpretation, at the Baseline Visit (Visit 2).
11. Subject has a known or suspected allergy, hypersensitivity, or clinically significantintolerance to guanfacine hydrochloride, or any components found in SPD503.
12. Subject has a history of alcohol or other substance abuse or dependence, as defined byDiagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text RevisionÒ (DSM-IV-TRÒ; with the exception of nicotine) within the last 6 months.
13. Subject has a history of a seizure disorder (other than a single childhood febrileseizure occurring before the age of 3 years) or the presence of a serious tic disorderincluding Tourette's syndrome.
14. Subject has a known history or presence of structural cardiac abnormalities, seriousheart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinicallysignificant heart block), exercise related cardiac events including syncope and presyncope, or clinically significant bradycardia.
15. Subject with orthostatic hypotension or a known history of controlled or uncontrolledhypertension.
16. Current use of any prohibited medication or other medications, including herbalsupplements, that affect BP or heart rate or that have central nervous system (CNS)effects or affect cognitive performance, such as sedating antihistamines anddecongestant sympathomimetics (inhaled bronchodilators are permitted) or a history ofchronic use of sedating medications (ie, antihistamines) in violation of the protocolspecified washout criteria at the Baseline Visit (Visit 2).
17. Subject has a medical condition, other than ADHD, that requires treatment withmedications that have CNS effects and/or affect performance.
18. Subject is female and is pregnant or currently lactating.
19. Subject failed screening or was previously enrolled in this study.