Table 3.

Schedule of assessments

Assessments	Screening visit and initial assessments	Randomisation	Start of IMP (within 2–3 months prior to surgery)	Preoperative assessments (within 21 days prior to surgery)	Surgery	Postoperatively/ discharge (within 14 days postsurgery)	3 Months postoperatively (±21 days)	6 Months post operatively (±21 days)	12 Months post operatively (±21 days)
Informed consent	X
Eligibility assessment	X
Demographics	X
Medical history and DCM characteristics	X
Concomitant medication	X			X			X	X	X
Blood tests (FBC, LFT, E/U/C, TFTs)	X			X			X	X	X
ECG	X
Urine analysis	X
Pregnancy test	X
Randomisation		X
Neurological examination	X			X		X	X	X	X
mJOA	X			X			X	X	X
30 m Walk test	X			X			X	X	X
GRASSP-cervical myelopathy	O			O			O	O	O
SCIMv3	O			O				O
WHO performance status				X
Neck disability index	O			O		O	O	O	O
VAS pain	X			X		X	X	X	X
SF-36	X			X			X	X	X
EQ5D/health resource usage	X			X			X	X	X
Quick-DASH	O			O			O	O	O
Carer QoL (substudy)	X			X			X	X	X
Review of AEs			X	X		X	X	X	X
Dosing diary	X
Dispensing of IMP			X			X	X
Serum sample for PK studies	X			X	X		X	X	X
Compliance assessment				X		X	X	X
IMP review				X		X	X	X
Respiratory physiology and muscle function				X				X
MRI				X				X
Gait lab (substudy)				X			O	X
Surgery details					X
Surgery complications						X	X	X	X
Hospital discharge						X
CSF sample					O

X: mandatory assessment; O: optional assessment

DCM, degenerative cervical myelopathy; IMP, investigational medicinal product; mJOA, modified Japanese Orthopaedic Association; VAS, visual analogue scale.