Demyelination was judged to be there if conduction velocities were slowed and the late-response latencies were substantially delayed significantly. Median-nerve mononeuropathy at the wrist was judged to be present when there was prolonged engine terminal latency or slowed median-nerve sensory velocity with disproportionate slowing in the palm-to-wrist segment, or both. The four affected topics, all of whom acquired diffuse slowing of conduction, were also considered to have a median-nerve mononeuropathy at the wrist, since the median-nerve electric motor terminal latency was much more prolonged than the ulnar-nerve motor terminal latency .These estimates were predicated on a 12-month extrapolation of data on freedom from target-lesion revascularization and duplex ultrasonographic data concerning restenosis from the LEVANT 1 trial. The populace of 476 patients who underwent randomization accounted for an anticipated 15 percent loss of patients from the final analysis owing to study withdrawal or missing imaging data. The principal efficacy and safety end points were analyzed on a modified intention-to-treat basis through the close of the 12-month follow-up window on day 395. Major patency was calculated by using an asymptotic likelihood-ratio chi-square check for inequality of binomial proportions .025) with a noninferiority margin of 5 %age factors. Additional prespecified sensitivity analyses included worst-case analyses , and 476 patients were randomly assigned, in a 2:1 ratio, to undergo angioplasty with a drug-coated balloon or standard angioplasty .