Table 4.

MND-SMART visit and assessment schedule

Appointment	Time	Informed consent	Inclusion/exclusion review	Eligibility confirmation	Demography	Disease history	Medical history	Current medications	Safety bloods	ECG	Suicide ideation (CSSRS)	Pregnancy test	Randomisation	FVC	ALSFRS-R and King’s staging*	EQ-5D-5L	HADS	ECAS†	Substudies	Research bloods	Drug supply	Titration up	Compliance check	Adverse events
1 Screening		x	x	x	x	x	x	x	x	x	x	x‡							x					x
2 Baseline	Time 0		x	x				x				x§	x	x	x	x	x	x	x	x	x	¶		x
3, 4, 5**	Weeks 1, 2 and 3							x														x	x	x
6, 7, 9, 10, 12, 13**	Months 2, 4, 8, 10, 14, 16							x							x				x		x		x	x
8††	Month 6							x						x	x	x	x		x	x	x		x	x
11††	Month 12							x						x	x	x	x	x	x	x	x		x	x
14††	Month 18							x						x	x	x	x	x	x	x	x		x	x
15, 16, 17 …**	Months 20, 22, 24 …							x							x						x		x	x

*Modified King’s staging will take place at remote appointments.

†This assessment includes an interview with a partner/relative/friend/carer if the participant has consented. If an arm is dropped the investigational medicinal product (IMP) dose should be halved at the next scheduled appointment and participants then complete the two treatment cessation appointments. Appointments from 15 onwards are the same to be repeated every 2 months.

‡For women of childbearing potential.

§If more than 7 days from previous test.

¶Start IMP.

**These appointments can be completed using video conferencing or telephone call.

††These appointments should be completed face to face wherever possible.

ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised; CSSRS, Columbia-Suicide Severity Rating Scale; ECAS, Edinburgh Cognitive and Behavioural ALS Screen; FVC, forced vital capacity; HADS, Hospital Anxiety and Depression Scale; MND-SMART, Motor Neuron Disease-Systematic Multi-Arm Adaptive Randomised Trial.