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Comparison of baseline factors and outcome measures between unblinded LABEL patients and blinded INVEST control-arm patients
LABEL (n = 19)^{^a} INVEST Control Arm (n = 16)^{^b} P Value
Age, mean (SD) 74.6 (13.6) 74.3 (9.4) 0.94
Sex, (No.) (%) female 11 (57.9) 12 (75.0) 0.48
RDQ, mean (SD) 
    Baseline 18.1 (4.0) 17.6 (4.6) 0.73
    Day 1 improvement^{^c} 0.49 (3.3) – –
    Day 3 improvement 0.41 (1.4) 5.3 (5.8) 0.006
Average 24-hour pain, mean (SD) 
    Baseline 6.5 (2.6) 7.4 (2.1) 0.27
    Day 1 improvement 1.4 (2.9) 3.8 (3.2) 0.03
    Day 3 improvement 0.72 (1.4) 2.9 (3.4) 0.04


a In the LABEL study, 17/19 precrossover outcome measures were available at day 1, and 11/19 precrossover outcome measures, at day 3. 


b For INVEST, outcome measures were available for all 16 patients at days 1 and 3.


c –indicates day 1 RDQ scores for INVEST patients were not available.