TABLE 4.

Efficacy analyses across ALSFRS‐R baseline thresholds

	Percent response across ALSFRS‐R baseline thresholds, primary endpoint				ALSFRS‐R MMRM change from baseline to week 28 secondary endpoint
ALSFRS‐R baseline score	n (%) total participants	% MSC‐NTF	% placebo	P‐Value	n (%) total participants	MSC‐NTF LS mean (SE)	Placebo LS mean (SE)	Delta	P‐Value
≥34	68 (36)	37.9	15.4	.163	57 (30)	−1.58 (1.13)	−4.32 (0.96)	2.74	0.057
≥33	83 (44)	35.1	15.2	.088	69 (37)	−2.36 (1.01)	−4.58 (0.91)	2.23	0.092
≥32	96 (51)	37.0	16.0	.056	78 (41)	−2.22 (0.90)	−4.32 (0.87)	2.10	0.081
≥31	100 (53)	35.4	15.4	.043	80 (42)	−2.44 (0.89)	−4.83 (0.86)	2.39	0.045
≥30	115 (61)	35.7	16.9	.103	92 (49)	−3.14 (0.82)	−5.53 (0.81)	2.39	0.032
≥29	123 (65)	34.5	18.5	.056	97 (51)	−3.66 (0.82)	−5.77 (0.78)	2.11	0.054
≥28	131 (69)	36.5	19.1	.022	105 (56)	−3.49 (0.78)	−5.58 (0.75)	2.09	0.048
≥27	138 (73)	35.4	20.5	.026	110 (58)	−3.95 (0.76)	−5.89 (0.72)	1.94	0.06
≥26	145 (77)	34.7	20.5	.053	116 (61)	−4.61 (0.75)	−5.81 (0.75)	1.20	0.247

Note: Hypothesis testing performed using logistic regression adjusted for baseline ALSFRS‐R total score, duration from onset of symptoms to first treatment, site of onset (Limb versus Limb & Bulbar). Riluzole use at baseline and ALSFRS‐R slope pre‐treatment were used to test the hypothesis of an OR of 1 between the two treatment groups.