2.5.2. Secondary endpoints.
Change)Sleep disturbance
SECONDARY
The secondary endpoints will include the following:Changes from baseline after 8 weeks of treatment in:
Quality of life (EQ-5D-3L)Treatment satisfaction of clinical subjects (Patient Global Impression of Change)Treatment satisfaction of the investigator (Clinician Global Impression of Change)Sleep disturbance (Daily Sleep Interference Scale)Medication adherence index (Morisky medication adherence scale 8-item version)Frequency, dose, and duration of rescue medication use after administration of the study drug