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Number of subjects Total Site 101 Site 102 Site 103

Allocated 126 42 42 42
Not used 4 0 4 0
Enrolled 122 42 38 42
Drop-outs 13 9 2 2
Discrepant files 2 0 2 0
Lost to follow up 6 0 4 2
Completed study 101 33 30 38

Parameter Laser A (active) Laser B (sham)


Patient 53 48
Baseline value VAS (mean±SD) 6.16±2.05 6.04±1.89
Male (number) 31 33
Female (number) 22 15
Age range (years) 30-80 25-80
Laser A (active) Laser B (sham) Total (group A+B)
Number % Number % Number %
Randomized enrollment 62 100 60 100 122 100
Complete treatment 1 62 100 57 95 119 97.5
Complete treatment 3 59 95.2 55 91.2 114 93.4
Complete treatment 6 55 88.7 49 81.2 104 85.2
Complete treatment 9 55 88.7 50 88.3 105 86.1
Complete treatment 12 55 88.7 50 88.3 105 86.1
30 day follow up 53 85.5 48 80 101 82.8
Drop out/termination 6 9.6 7 11.7 13 10.7
Lost to follow up 3 4.8 3 5 6 4.9
Discrepant data files 0 0 2 3.3 2 1.6

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