Differences to Statistical Analysis Plan
SIDE EFFECT
For side effects, in the SAP we stated we would examine only new side effects (i.e. not previously experienced), but changed to any side effects following discussion of presentation of findings. By only examining new side effects, this did not allow us to show change in side effects from baseline. It was apparent that the proportion experiencing some side effects went down on treatments compared with baseline, whereas some went up. By allowing analysis of all we were able to demonstrate this. It also meant participants could record the same side effect on two different drugs, which would not be possible otherwise. The full distribution of participants reporting side effects for baseline and on each of the therapies is presented for completeness.