Table 2.

Study flow chart.

	V0	V1	V2	V3	V4	V5	V6	V7	V8	V9	V10	V11	V12	V13
	-7d ~ 0d	W0	W4 ± 3d	W8 ± 3d	W12 ± 7d	W16 ± 3d	W20 ± 3d	W24 ± 7d	W28 ± 3d	W32 ± 3d	W36 ± 7d	W40 ± 3d	W44 ± 3d	W48 ± 7d
	Screening	Baseline	phone call	phone call	visit	phone call	phone call	visit	phone call	phone call	visit	phone call	phone call	visit
Patient information
Informed consent	X
Demographics	X
Medical history	X
TCM syndrome differentiation	X
Concomitant treatment history	X		X	X	X	X	X	X	X	X	X	X	X	X
Screening assessment
Pregnancy test in fertile women	X
Neuro-electrophysiological examination	X
Inclusion/exclusion criteria	X
Randomization		X
Efficacy outcomes
ALSFRS-R	X	X			X			X			X			X
ROADS		X			X			X			X			X
ALSAQ-40		X			X			X			X			X
Forced vital capacity	X	X			X			X			X			X
SSCMS		X			X			X			X			X
Endpoint event					X			X			X			X
Safety outcomes
Adverse events			X	X	X	X	X	X	X	X	X	X	X	X
Vital signs and physical examination	X	X			X			X			X			X
Laboratory tests	X				X			X			X			X
Electrocardiography	X				X			X			X			X
Others
Study treatment dispensation		X			X			X			X
Study treatment compliance					X			X			X			X