Table 1.

Study schedule

^*Only those women of reproductive potential

^**Confirm documented disease status

^****CADSS only if indicated during adverse event assessment

^Including complementary medicine use

^#Eligibility data to be used as a baseline as long as within 3 days of each other

^«Day 7 and 21 review may be conducted via telehealth if deemed appropriate

⁼Optional sleep secondary aim 1 only—days 0–14