Table 2

Clinical trial outcome measures

Parameter	Assessments/measures	Timing (see also figure 4)	Safety issue
Primary end point
Gastroduodenal bleeding	SAE report	Continuous observation	Yes
Secondary end points
Adverse events	Adverse event monitoring, SAE/SUSAR report	Continuous observation	Yes
Spasticity	Modified Ashworth Scale, antispastic medication	Follow-up 1 and 2	Yes
Neuropathic pain	Neuropathic Pain Scale, pain medication	Baseline, follow-up 1 and 2	Yes
Severity of SCI	ASIA Impairment Scale	Baseline, follow-up 1 and 2	No
Motor function	Upper and lower extremity motor score	Baseline, follow-up 1 and 2	No
Sensory function	Pin prick, light touch	Baseline, follow-up 1 and 2	No
Lesion height	Motor and sensory level, zone of partial preservation, if applicable	Baseline, follow-up 1 and 2	No
Ibuprofen levels	Blood and CSF collection	Pharmacokinetics 1, 2 and 3*	No
Serum/CSF protein levels	Blood and CSF collection	Pharmacokinetics 1, 2 and 3*	No
Heterotopic ossifications	Ultrasound of the hip joints, MRI, if applicable	Baseline, follow-up 1 and 2	No
Other end points
Laboratory abnormalities	Blood and urine collection	Safety 1, 2, 3 and 4*	Yes
Cardiac arrhythmia	ECG	Baseline, follow-up 1 and 2	Yes
Deep vein thrombosis	Ultrasound of pelvic and lower extremity veins	Baseline, follow-up 1 and 2	Yes
Circulatory disturbance	Blood pressure and heart rate	Baseline, safety 1, 2	Yes
Clinical observation	Epigastric pain/pain projected to the shoulder tip	Baseline, safety 1, 2 and 3*	Yes
Feasibility of recruitment	Screening protocol	Screening	No

Differences between the cohorts are based on the course of an extended intervention. In cohort II, additional pharmacokinetic and safety assessments are scheduled (indicated by asterisks).
ASIA, American Spinal Injury Association; CSF, cerebrospinal fluid; SAE, serious adverse event; SCI, spinal cord injury; SUSAR, serious unexpected suspected adverse reaction.