Table 2. Schedule of assessments.

Assessment/Procedure	Screening / Baseline	Surgery	1 week	2 week	3 month	6 month	12 month
			± 1d	± 1d	± 7d	± 30d	± 30d
Participant informed consent	X	X
Inclusion criteria	X
Exclusion criteria	X
Medical and surgical history	X
Demographics	X
Concomitant medication	X		X	X	X	X	X
Safety reporting	X		X	X	X	X	X
Surgery		X a
Sensory outcome assessment	X	X b			X	X	X
Ultrasound Examination					X	X	X
Wound examination			X	X	X	X	X

^a In the event of repeat surgery, the 3-month, 6-month and 12-month follow-up visits will be performed from the date of the first surgery.

^b Sensory outcome assessment to be completed pre-operatively.