Table 4.

Percentage of subjects with clinically meaningful outcomes (end of treatment versus baseline)

Population	N	Δ PI ≥30%	Δ ODI ≥6%	PGIC: improved or much improved	Less analgesics
Per-protocol	30	33%	50%	17%	22%
Discectomy	10	60%	40%	43%	29%
Decompression	14	21%	57%	8%	17%
Fusion	6	17%	50%	0%	25%

Notes: PI, PGIC, and analgesic data are reported as change between end of treatment score (Day 45) and baseline score, except for change in PI, which includes one subject who reported a final PI score at day 37. ODI data are reported as change between Day 46 follow-up score and baseline score. Change in PGIC and analgesic scores represents only subjects who reported final PGIC and analgesic consumption scores at the end of the defined treatment period (Day 45) and excludes six per protocol subjects (two discectomy responders, one decompression responder, one decompression non-responder, two fusion non-responders) who reported final PGIC and analgesic consumption at 5 weeks and one per protocol subject (one discectomy responder) who reported final PGIC and analgesic consumption at 4 weeks.

Abbreviations: Δ, change; N, number; ODI, Oswestry Disability Index; PGIC, Patient Global Impression of Change; PI, pain intensity.