Table 2.

Data collection and schedule of assessments

	Screening	Consent	Medication confirmation	Follow-up	Closeout
Visit number	0	1	2	3…X	X+1
Day	0	0±14	Within 7 days	Every 30±7	End of Follow-up
Informed Consent		X
Randomization	X
Demographics	X				X
Medical History	X				X
Medications	X				X
Vital Signs	X				X
Laboratory Values	X				X
Study Drug Dispensed		X	X	X
Study Close Out					X
Endpoints					X