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. 2022 Jun 3;66(1):39–49. doi: 10.1002/mus.27511

TABLE 1.

Baseline demographics of phase 2B mITT population

Placebo (N = 68) NP001 (N = 68) Total (N = 136)
Male/female, n (%male) 46/22 (67.6%) 45/23 (66.2%) 91/45 (66.9%)
Age in years, mean (SD) a 56.6 (10.75) 57.8 (10.89) 57.2 (10.80)
Months since ALS symptom onset (SD) b 18.83 (8.13) 19.07 (8.40) 18.97(8.23)
Familial/sporadic ALS, n (%familial) c 14/54 (20.6%) 2/66 (2.9%) 16/120 (11.8%)
Bulbar, n (%) 10 (14.7%) 7 (10.3%) 17 (12.5%)
Limbs, n (%) 58 (85.3%) 61 (89.7%) 119 (87.5%)
Concurrent riluzole use, n (%) 45 (66.2%) 45 (66.2%) 90 (66.2%)
ALSFRS‐R score at baseline, mean (SD) 36.7 (5.64) 37.7 (5.07) 37.2 (5.35)
Hs‐CRP at baseline, mg/L, mean (SD) 3.99 (5.49) 4.38 (4.35) 4.18 (4.94)

Abbreviation: N (n), number of participants.

a

Age is calculated relative to the date of informed consent.

b

Months from ALS symptom onset to randomization.

c

Genetic testing information of familial ALS in the Supporting Information Table S1 in the Appendix.