Table 2

RESCUE-ALS clinical visit schedule

Time and event schedule for clinical visits
Visit	−1	0	1	2	3	4	5
Phase	Screening	Baseline		Treatment period			EOS
Week	−4	0	6	12	24	36	40
Day	−28 to −1	1	42	84	168	252	280
ICF signed	X
Eligibility review	X	X
Medical history and prior med assessment	X
Physical examination	X	X		X	X	X
Brief neurological examination	X	X		X	X	X
Height assessment	X
Weight assessment	X	X		X	X	X
Urine drug test	X
HIV/viral hepatitis screen	X
Serum pregnancy test	X
Urine pregnancy test		X		X	X	X
Vital signs	X	X		X	X	X
12-lead ECG	X	X		X	X	X
Clinical laboratory (blood)	X	X		X	X	X	X
Urinalysis	X	X		X	X	X
Concomitant medication	X	X	X	X	X	X	X
Randomisation		X
Dispense/return drug		X		X	X	X
Schedule next visit	X	X	X	X	X	X
PD sampling (whole blood, plasma, urine)		X		X	X	X
PK sampling (blood)				X	X	X
Adverse events	X	X	X	X	X	X	X
Electromyography (eg, MUNIX, MUSIX, MScanFit)		X		X	X	X
ALSFRS-R	X	X		X	X	X
FVC	X	X		X	X	X
ALSSQOL-SF		X		X	X	X
Health utilisation form (eg, percutaneous endoscopic gastrostomy (PEG) tube, noninvasive ventiliation (NIV), wheelchair)		X		X	X	X
Falls Questionnaire				X	X	X
PGI (patient global impression)		X		X	X	X
CGI (clinical global impression)		X		X	X	X
Columbia-Suicide Severity Rating Scale (C-SSRS)	X	X	X	X	X	X	X

ALS, amyotrophic lateral sclerosis; ALSFRS-R, ALS Functional Rating Score-Revised; EOS, end of study; FVC, forced vital capacity; ICF, informed consent form; MUNIX, motor unit number index; MUSIX, motor unit size index; PD, pharmacodynamic; PK, pharmacokinetic.