Table 2.

Study visits

	Consent	Visit 1		Day of Surgery	Visit 2	Visit 3
		Part A	Part B
Date of Visit	Must occur prior to start of Visit 1, but can be same day as Visit 1	Any time after consent is signed	Must occur no more than 60 days after Part A	Must occur no more than 90 days after Part B (can occur same day as Visit 1)	1 month +/− 14 days after surgery	14 weeks +/− 4 weeks
Cycle Timing of Visit	Can occur any day	Can occur any day	Must occur on cycle days 6–12 or 18–25	Can occur any day (unless combined with Visit 1, Part B)	Preferably on cycle day 6–12	Must occur on cycle days 6–12 or 18–25
CRFs
Registration	x
Eligibility	x
WERF EPHect Standard Questionnaire		x
EHP-30		x			x	x
Pain Scale			x		x	x
Biospecimen Collection			x		x	x
Prior Medical History			x
Concomitant Medications			x (or on Day of Surgery	X (or at Visit 1 Part B)	x	x
Surgical Form				x
Surgical Worksheet				x
Post-Operative Form				x
End of Study						x
Protocol Deviation
Adverse Event Log
Serious Adverse Event