PDSS is a self-rated assessment of daytime sleepiness that was completed at screening, baseline, and visits 1 through 9. The subjects responded to 8 questions related to sleepiness using a Likert scale rating (never = 0; always = 4). Higher scores on the PDSS indicated greater levels of sleepiness.
PGA is a parent-rated variation of the CGI in which the parent or caregiver evaluates the subject's symptom severity. The PGA was completed between screening and baseline visits and again at visit 6. Responses from the PGA were dichotomized into 2 categories: "improvement" (included the responses "very much improved" and "much improved") and "no improvement" (all other responses).
PSERS is a clinician-rated scale used to assess the severity of AEs such as dullness, tiredness, listlessness, headache, stomach ache, loss of appetite, and trouble sleeping. The PSERS was completed at screening and visits 1 through 9. Severity of AEs was rated as none, mild, moderate, or severe.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
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|SOURCE Shire plc|
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