Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years
Brief Summary: This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.


Options:
A: Inclusion Criteria:

* 6-17 years old
* diagnosis of ADHD according to ICD-10 or DSM-IV criteria
* new initiation onto an approved medication to treat ADHD

Exclusion Criteria:

* no specific exclusion criteria
B: Inclusion Criteria:

* DSM-IV Diagnosis of trichotillomania
* DSM-IV diagnosis of ADHD
* Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study.

Exclusion Criteria:

* History of moderate or severe adverse event, related to MPH
* History of any psychotic disorder
* Current drug abuse, acute psychotic or affective disorder
C: Inclusion Criteria:

* Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview
* Clinical Global Impression-Severity score of at least 4 for ADHD
* Resided with primary caretaker for at least 6 months prior to study entry

Exclusion Criteria:

* History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder
* Current major depression or panic disorder
* Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)
* Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable
* Need for chronic use of other medications with central nervous system effects
* Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test
* History of structural heart defects, syncope, or fainting while exercising
* Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry
* Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests
D: Inclusion Criteria:

To be eligible for inclusion, each subject must fulfill each of the following criteria at the Entry visit:

* The subject participated in the antecedent SPD485-409 study, and a) completed all required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose Optimization period without achieving an acceptable condition as defined by the antecedent SPD485-409 study.
* Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Entry.
* Subject's ECG results are within the normal range or not clinically significant at Entry as judged by the Investigator in conjunction with the central reader.
* Females must have a negative urine pregnancy test at Entry and agree to use acceptable contraceptives throughout the study period and for 30 days the last dose of IP.
* Subject and parent of legally authorized representative (LAR) are able, willing and likely to fully comply with study procedures and restrictions.
* Written, signed and dated informed consent to participate in the study must be given by the subject's parent or LAR, in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
* There must be documentation of the subject's assent to participate in the study indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions. Failure to object is not to be considered assent.

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria are met at Entry:

* Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance, AE, or a serious adverse event (SAE).
* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
* Subject is taking any medication that is excluded.
* Female subject who is pregnant or lactating.

Answer: C