Table 7. Study schedule.

Visit	V1	V2	V3	V4
Day	Screening Day 3	Baseline Day 0	5 Weeks ± 2 Days	10 Weeks ± 2 Days
Informed consent	√	X	X	X
Demographics and Medical history	√	X	X	X
Screening and Enrolment	√	X	X	X
Physical examination & vital parameters	√	√	√	√
Study Medication Dispensing	X	√	X	X
Actiwatch (sleep actigraphy)	√	√	√	√
Pittsburgh Sleep Quality Index (PSQI)	√	√	√	√
Hamilton Anxiety Rating Scale (HAM-A)	√	X	√	√
Mental alertness on rising	√	X	√	√
Sleep quality	√	X	√	√
Sleep Log	X	√	√	√
Medication Compliance	X	X	√	√
Adverse Events	√	√	√	√
Concomitant Illness	√	X	X	X
Concomitant medication	√	√	√	√
Study Completion/Termination	X	X	X	√