10:42 Dec 29, 2008
Subject eligibility based on the screening diary Based on the entries of 7 consecutive days within 14 days prior to Visit 2, inclusion criteria #5 and #6, and exclusion criterion #f, must be confirmed. During these 7 consecutive days, the subject must also comply with exclusion criteria #q and #s to allow for the time of prohibited CBT and CNS-active drugs (see Sections 3.2.2 & 3.2.3). Exclusion criterion #q: Treatment with cognitive behavioral therapy (CBT) within 1 week prior to the first of the 7 days of screening Sleep Diary where eligibility is checked (criteria #5, #6, #f). Exclusion criterion: #s Unwillingness to refrain from prohibited central nervous system (CNS)-active drugs for 5 half-lives of the respective drug (but at least 1 week) prior to the first of the 7 days of screening Sleep Diary where eligibility is checked (criteria #5, #6, #f), and until 1 day after the last administration of study drug. |