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

Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).

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

Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).

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 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.