Table 2

MS-SMART individual visit schedule

Clinic visit number	0	MRI visit	1	2	3	4	5	6	7	8		9		Unscheduled visit
Visit type	Screening		Baseline	Titration							MRI visit	End of study	Follow-up (Tel.)
Visit week			0	4	8	12	24	36	48	72	96	96	100
Window				±1 week	±1 week	±1 week	±2 week	±2 week	±2 week	±2 week		±2 week	±4 days
Informed consent	x
Inclusion/exclusion criteria review	x		x
Demography	x
Review of medical and MS history	x													x
EDSS-review (treating physician)	x
Physical examination	x								x			x		x
Vital signs	x								x			x		x
BDI-II	x
Safety bloods	x			x	x	x	x	x	x	x		x		x
Compliance assessment				x	x	x	x	x	x	x		x
Relapse assessment (count/grade)	x		x	x	x	x	x	x	x	x		x		x
Record of adverse events			x	x	x	x	x	x	x	x		x	x	x
Concomitant medication	x		x	x	x	x	x	x	x	x		x		x
Randomisation			x
Blinding questionnaire												x
MRI brain scan		x					x				x
EDSS—(assessing physician)			x						x			x
MSFC			x						x			x
SDMT			x						x			x
SLCVA			x						x			x
MSIS29v2			x						x			x
MSWSv2			x						x			x
NFI			x						x			x
NFI, NPRS, NPS and BPI			x						x			x
EQ-5D			x						x			x

Study-specific activity shown for each study visit, see text for additional details.
BDI-II, Beck Depression Inventory II; BPI, brief pain inventory; EDSS, Expanded Disability Status Scale; EQ-5D, EuroQol five dimensions questionnaire; MSFC, multiple sclerosis functional composite; MS-SMART, Multiple Sclerosis -Secondary Progressive Multi-Arm Randomisation Trial; MSIS29v2, multiple sclerosis impact scale (29 item) version two; MSWSv2, multiple sclerosis walking scale version two; NFI, neurological fatigue index; NPRS, numeric pain rating scale; NPS, neuropathic pain scale; SDMT, symbol digit modalities test; SLCVA, Sloan low-contrast visual acuity.