Table 1.

Schedule for assessments

		Assessment period															Follow-up period		Dis- charge	Termi- nation
		Pre-observation period				Observation period
			Pre-enrolment	Qualifi-cation	Pre-dosing	Day 1						Day 2	Day 3	Day 8	Day 31	Day 91	Day 181	Day 366
						0 hour	1 hour	2 hour	4 hour	6 hour	12 hours
Informed consent		x
Patient characteristics			x¶
Administration of study product						x
Ability assessment	mRS		x**												x	x		x	x
	Barthel Index														x	x		x
Function assessment	NIHSS		x††	x‡‡								x		x	x	x			x
QOL assessment	EQ-5D-5L														x	x		x
Clinical laboratory tests	Haematology		x††		x							x	x	x	x	x	x	x		x
	Biochemistry		x††		x							x	x	x	x	x	x	x		x
	Blood coagulation test		x††		x							x	x	x	x	x	x	x		x
	Biomarker*				x								x	x
	Urinalysis		x††		x							x	x	x	x	x	x	x		x
Imaging examinations	Safety assessment		x††									x		x¶¶	x
	Infarct volume†				x§§									x¶¶	x
	Penumbra region volume† ‡				x
Body measurements	Height, weight		x††
Vital signs	Blood pressure, pulse		x		x		x	x	x	x	x	x	x	x	x	x	x	x	x	x
	Body temperature		x		x			x	x	x		x	x	x	x	x	x	x	x	x
Oxygen saturation	SpO2§		x		x		x	x	x	x	x	x	x	x	x	x	x	x		x
Medical examination	Medical examination and interview		x		x							x	x	x	x	x	x	x	x	x

*Assessed in the cohort three only.

†Assessed at the central imaging analysis organisation.

‡Performed at some study sites.

§In addition to the scheduled period in the table, SpO₂ is assessed at 15 min, 30 min, 45 min, 1 hour 15 min, 1 hour 30 min, 1 hour 45 min, 2 hour 15 min, 2 hour 30 min, 2 hour 45 min, 3 hour 15 min, 3 hour, 3 hour 15 min, 3 hour 30 min, 3 hour 45 min, 4 hour 30 min, 5 hour, and 5 hour 30 min post-dose.

¶Pregnancy test is performed in premenopausal women or unknown women whether menopause.

**The mRS before ischaemic stroke onset is assessed based on interview from patients or their family.

††Data before obtaining consent are acceptable.

‡‡Assessed at least 4 hours after enrolment.

§§Imaging data after standard treatment are accepted for patients who have undergone standard treatment (rt-PA intravenous or endovascular treatment).

¶¶Assessed once during Day five to Day 8.

mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; QOL, quality of life; SpO2, oxygen salutation of peripheral artery.