Comparison of baseline factors and outcome measures between unblinded LABEL patients and blinded INVEST control-arm patients

LABEL (n = 19)aINVEST Control Arm (n = 16)bP Value
Age, mean (SD)74.6 (13.6)74.3 (9.4)0.94
Sex, (No.) (%) female11 (57.9)12 (75.0)0.48
RDQ, mean (SD)
    Baseline18.1 (4.0)17.6 (4.6)0.73
    Day 1 improvementc0.49 (3.3)––
    Day 3 improvement0.41 (1.4)5.3 (5.8)0.006
Average 24-hour pain, mean (SD)
    Baseline6.5 (2.6)7.4 (2.1)0.27
    Day 1 improvement1.4 (2.9)3.8 (3.2)0.03
    Day 3 improvement0.72 (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.