Table 2.

Primary outcome, requirement for MV

		No MV	MV	RR (95% CI), p value*	OR (95% CI), p value
Intention-to-treat population
Intrathecal, n=261
	Sham procedure	66/131 (50%)	65/131 (50%)	..	..
	Intrathecal treatment	74/130 (57%)	56/130 (43%)	0·87 (0·66–1·13), 0·29	0·77 (0·47–1·25), 0·29
Intramuscular, n=215
	Equine antitoxin	60/108 (56%)	48/108 (44%)	..	..
	Human antitoxin	59/107 (55%)	48/107 (45%)	1·01 (0·75–1·36), 0·95	1·02 (0·59–1·74), 0·95
Per-protocol population
Intrathecal, n=254
	Sham procedure	64/128 (50%)	64/128 (50%)	..	..
	Intrathecal treatment	73/126 (58%)	53/126 (42%)	0·84 (0·64–1·10), 0·21	0·73 (0·44–1·19), 0·21
Intramuscular, n=213
	Equine antitoxin	59/106 (56%)	47/106 (44%)	..	..
	Human antitoxin	59/107 (55%)	48/107 (45%)	1·01 (0·75–1·37), 0·94	1·02 (0·59–1·75), 0·94

Data are n/n (%), unless stated otherwise. MV=mechanical ventilation. RR=relative risk. OR=odds ratio.

^*Measured using values in the intervention row.