Table 1.

Visit schedule

Action	Screening/baseline day 0 (−3 days)	Therapy day 1	Therapy day 2	Therapy day 3	Week 1 (±4 days)	Week 4 (±4 days)	Week 16 (±4 days)	Week 26 (±7 days)	Month 24 (±7 days)
Informed consent	X
Demographics	X
Inclusion/exclusion criteria	X
Medical history	X
Present complaints	X	X	X	X	X	X	X	X	X
MS relapse/ON recurrence						X	X	X	X
Concomitant medication	X	X	X	X	X	X	X	X	X
Physical examination	X*				X*	X*
Vital signs†	X	3 X	3 X	3 X	X	X
Body weight	X*				X*	X*
ECG	X*				X*
Routine laboratory‡	X				X	X		X
Urinalysis (if clinically indicated)	X*				(X*)	(X*)	(X*)	(X*)
Pregnancy test	X*
EPO antibodies (analysis in central lab)	X							X
Aquaporin 4 antibodies	X
Methylprednisolone therapy		X (standard of care)	X (standard of care)	X (standard of care)
EPO/placebo administration		X	X	X
AE reporting	X	X	X	X	X	X	X	X	X§
Neurological examination, EDSS¶	X				X	X	X	X	X
Randomisation	X
Refraction	X				X	X	X	X	X
OCT	X					X	X	X	X
LCVA	X				X	X	X	X	X
HCVA	X				X	X	X	X	X
CS	X				X	X	X	X	X
Perimetry	X				X	X	X	X	X
NEI VFQ-25	X							X	X
VEP	X					X	X	X	X
Routine MRI	X**							X††	(X)

*Test to be performed, but not recorded on CRF.

†CRF: only blood pressure.

‡CRF: only haemoglobin (Hb).

§(S)AE: to be reported only if related to investigational product.

¶CRF: only EDSS.

**Can be done after baseline as per local routine.

††Recommended.

AE, adverse event; CS, contrast sensitivity; EDSS, Extended Disability Status Score; EPO, erythropoietin; HCVA, high-contrast visual acuity; LCVA, low-contrast visual acuity; MS, multiple sclerosis; NEI VFQ-25, National Eye Institute Visual Functioning Questionnaire 25; OCT, optical coherence tomography; ON, optic neuritis; VEP, visual evoked potentials.