Created at	Source	Raw Value	Validated value
Dec. 8, 2022, 4 a.m.	usa	Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28;Pilot phase: Proportion of participants retained after 28 days	Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28;Pilot phase: Proportion of participants retained after 28 days