Seems like a miscalculated punt to me. It certainly is brave given that PAR do not need to report significance or p values at the 12 month readout according to the SAP. I expect to only see 95% confidence intervals reported. The only real important statistic here is the trend given the small sample size, but any separation between the placebo and treatment groups would be indicative of disease modifying effects. The worst case scenario would be if pain and function in the treatment group revert back to baseline.
Ideally we would want to see pain and function worsening in the placebo group and staying the same or getting better in the treatment group. I was hoping to see MRI results at the 12 month time point, but I'm not sure if PAR will be reporting on these.
Chart, page-3952
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