Table 3.

Primary and secondary end points.

Primary end point: safety	All adverse events will be recorded throughout the study period. All serious and unexpected adverse events will be reported to the IDMC.
Secondary end points: efficacy	Change of ISNCSCI total motor scores at the 52 nd week from the baseline.
	Sequential transition of ISNCSCI motor scores.
	Sequential transition of AIS classification.
	Sequential transition of ISNCSCI sensory scores.
	Sequential transition of modified Frankel classification.
	Sequential transition of the zone of partial preservation.
	Sequential transition of PainDETECT scores (Japanese version).
	Sequential transition of the Neuropathic Pain Symptom Inventory (Japanese version).
	Sequential transition of the modified Ashworth scale.
	Sequential transition of Spinal Cord Independence Measure version III (Japanese version).
Another end point: efficacy	Change of ISNCSCI motor scores at the 24th week from the baseline.

Abbreviations: IDMC, independent data monitoring committee; ISNCSCI, International Standards for Neurological Classification of Spinal Cord Injury; AIS, American Spinal Cord Injury Association Impairment Scale.