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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 improvementc 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.
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b For INVEST, outcome measures were available for all 16 patients at days 1 and 3.
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c –indicates day 1 RDQ scores for INVEST patients were not available.
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