Table 2.
aCTI + SOC ITT | SOC ITT | aCTI + SOC PP | SOC PP | |||
---|---|---|---|---|---|---|
Week 2 | n = 73 | n = 56 | ||||
Mean (SD) | 5.0 (3.5) | 5.4 (3.9) | 4.5 (3.3) | 5.0 (3.6) | ||
Range | 0–12 | 0–13 | 0–12 | 0–13 | ||
95 % CI | −0.9 to 0.3 | — | −1.1 to 0.3 | — | ||
P-value | 0.37 | — | 0.25 | — | ||
Month 1 | n = 78 | n = 67 | ||||
Mean (SD) | 3.7 (3.1) | 3.7 (3.4) | 3.5 (2.9) | 3.4 (3.1) | ||
Range | 0–10 | 0–11 | 0–10 | 0–11 | ||
95 % CI | −0.7 to 0.5 | — | −0.6 to 0.7 | — | ||
P-value | 0.80 | — | 0.91 | — | ||
Month 3 | n = 72 | n = 61 | ||||
Mean (SD) | 2.7 (2.6) | 3.1 (3.2) | 2.3 (2.4) | 2.6 (2.9) | ||
Range | 0–8 | 0–10 | 0–7 | 0–9 | ||
95 % CI | −1.0 to 0.2 | — | −1.1 to 0.3 | — | ||
P-value | 0.19 | — | 0.25 | — | ||
Month 6 | (n = 68) | (n = 60) | ||||
Mean (SD) | 2.0 (2.0) | 2.4 (2.7) | 1.9 (2.0) | 2.0 (2.6) | ||
Range | 0–8 | 0–10 | 0–8 | 0–10 | ||
95 % CI | −1.0 to 0.3 | — | −0.9 to 0.5 | — | ||
P-value | 0.29 | — | 0.55 | — | ||
Month 9 | n = 70 | n = 68 | ||||
Mean (SD) | 0.8 (1.5) | 1.5 (1.7) | 0.8 (1.5) | 1.4 (1.7) | ||
Range | 0–7 | 0–5 | 0–7 | 0–5 | ||
95 % CI | −1.3 to −0.1 | — | −1.3 to 0.01 | — | ||
P-value | 0.02 | — | 0.05 | — |
Abbreviations: CI, confidence interval; ITT, intent to treat; PP, per protocol; SD, standard deviation; SOC, standard of care.