Ann: PAR Expanded Access IND Cleared by US FDA, page-14

From the P2 trial results, at day 53 it seemed that the effects of PPS were wearing off to not be statistically significant to placebo but in later time stages, the placebo effect wore off more, and the treatment group plateaued resuming clinical/statistical significance....so it wouldn't surprise me to see further divergence in later stages.

Also, its been widely reported of people undergoing treatment had resumed physical activities that had not managed for years. This increase in activity would have some negative impact on pain scores. Very human to do so.

Important considerations on the P3 trial design.