Not sure I understand all your questions but I will do my best:
The placebo effect is still measured as part of the monitoring of controls. However you would expect that after unblinding at 6 months the effects would have diminished and after that the controls would reflect random "noise" from other non specific variables. The hope is that the random noise would be similar among both controls and treated patients so that the true effect of the treatment would be more apparent. But with such a small number of patients, if one or two patients experienced non random effects it might seriously change the outcome. However of a longer time period things would likely even out.
There are no new patients needed for control. Two patients are randomly selected from each cohort of 6 at the beginning of the trial and they remain controls throughout the trial. I don't understand what you mean.
The nocebo effect is taken care of by measuring the controls. If you take a look at the 120mc patient results you would get a good idea of the extent of both any placebo or nocebo effects, because the treatment completely failed even though all the patients expected to have benefit and 4 of the 6 actually had implants but still derived no benefit.
The null hypothesis is that there is no significant difference between treated patients and controls. It is not "elastic" at all. If there is a statistically signifiant difference (at probably the 0.05 confidence level), the null hypothesis will be rejected and the alternative hypothesis accepted. The confidence level reflects the degree of certainty that the result is a true result and not a lucky chance effect.
What does change are the patients symptoms over time. So at one point in time (eg 6 months) there was no significant difference between controls and treated patients. As the treatment works and treated patients benefit, their symptoms and scores improve so at 18 months there is statistical significance. Now at 2 years something appears to have happened in the 40mc group and perhaps the 120mc group resulting in a drop in the measured benefit compared with the controls. So far we don't know any more than this.
LCT Price at posting:
3.0¢ Sentiment: Hold Disclosure: Held
