Table e-1: Programming parameters
Parameter / Annual Visit(year)* / n / mean / standard
deviation / min / 25th / median / 75th / max
Amplitude (volts)† / 2 / 98 / 6.6 / 1.6 / 2.75 / 5 / 7.35 / 7.5 / 10
3 / 93 / 6.3 / 2.0 / 0 / 5 / 7.5 / 7.5 / 10
4 / 88 / 6.6 / 1.7 / 0 / 5.5 / 7.5 / 7.5 / 9.5
5 / 78 / 6.5 / 1.9 / 0 / 5 / 7.5 / 7.5 / 10
Cycle off time (min) / 2 / 99 / 3.4 / 1.7 / 0.08 / 2 / 3 / 5 / 5
3 / 87 / 3.3 / 1.7 / 0.17 / 2 / 3 / 5 / 5
4 / 84 / 3.3 / 1.6 / 0.5 / 2 / 3 / 5 / 5
5 / 78 / 3.2 / 1.6 / 0.03 / 2 / 3 / 5 / 5
Cycle on time (min) / 2 / 99 / 1.0 / 0.4 / 0.25 / 1 / 1 / 1 / 4
3 / 88 / 1.0 / 0.4 / 0.002 / 1 / 1 / 1 / 4
4 / 84 / 1.1 / 1.1 / 0.5 / 1 / 1 / 1 / 10
5 / 78 / 1.2 / 1.0 / 0.02 / 1 / 1 / 1 / 6
Frequency (Hz) / 2 / 100 / 156.4 / 25.7 / 70 / 145 / 145 / 185 / 185
3 / 93 / 152.6 / 35.7 / 3 / 145 / 145 / 185 / 240
4 / 88 / 159.8 / 21.0 / 100 / 145 / 145 / 185 / 200
5 / 78 / 162.5 / 20.1 / 140 / 145 / 145 / 185 / 200
Pulse width (µs) / 2 / 100 / 94.2 / 12.8 / 60 / 90 / 90 / 90 / 150
3 / 93 / 98.1 / 23.9 / 60 / 90 / 90 / 90 / 210
4 / 88 / 97.2 / 17.0 / 60 / 90 / 90 / 90 / 150
5 / 78 / 99.2 / 17.6 / 60 / 90 / 90 / 120 / 150
Programming parameter changes were allowed after the 1 year visit. Prior to the 1 year visit, subjects were required to use 5.0 or 7.5 volts, cycling time of 5 minutes off and 1 minute on, frequency of 145 or 185 Hz, and pulse width of 90 µs. Exceptions to these parameters were allowed in response to an adverse event. *Year 1 not shown due to the limited number of parameters allowed during the Unblinded Phase. †Amplitude of 0 volts indicated that the subject was turned to zero volts for reasons including battery end of life, an adverse event, or to test whether the stimulation is beneficial.