RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Failed to meet primary endpointThey have proved the device or even " sham" device worked against a placebo. Only true placebo imo is people doing same therapy and some using them and some not and this has been proven in many other studies. This is not a pill and the fda are not stupid people either and can see the difference and the outcomes if we can besides an endpoint being met or not.