Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.

Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.