Induction Of Experimental Cell Division To Generate Cells With Reduced Chromosome Ploidy Nuria Marti Gutierrez by Nuria Marti Gutierrez, Aleksei Mikhalchenko, Maria Shishimorova, Daniel Frana, Crystal Van Dyken, Ying Li, Hong Ma, Amy Koski, Dan Liang, Sang-goo Lee, Daniel Eyberg, Zahra Safaei, Eunju Kang, Yeonmi Lee, Thomas O’leary, David Lee, instant download after payment.

Chronic low back pain (CLBP) afects over half a billion people worldwide. Current pharmacologic treatments ofer limited efcacy and carry substantial risks, warranting the development of safe and efective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efcacy and safety of VER-01 in CLBP. It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure. The study met its primary endpoint in phase A, with a mean pain reduction of −1.9 NRS points in the VER-01 group (mean diference (MD) versus placebo = −0.6, 95% confdence interval (CI) = −0.9 to −0.3; P < 0.001). Pain further decreased to −2.9 NRS points in phase B, with efects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of −14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = −7.3, 95% CI = −13.2 to −1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44–1.27; P = 0.288), pain increased signifcantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0–1.0; P = 0.034). In phase A, the incidence of adverse events—mostly mild to moderate and transient—was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and efective treatmen