Chronic Lower Back Pain - the sleeping giant., page-155

"Future trial to include roughly same patient population as previous phase III -"

Roughly same number of patients, but FDA has agreed we can limit to patients who have had CLBP for less than 68 months. That is where we saw the best results.. (Before fibrosis sets in, according to SI)

That 68 months was the median for patients in our first phase 3 trial. However, the doctors deemed that to be "forever," and in practice would expect to use our treatment much, much earlier. Definitely before considering surgery, and some insurance plans will entertain surgery as soon as 6 months after other less invasive treatments fail.