The dropout rate is probably my biggest concern for this trial...

The dropout rate is probably my biggest concern for this trial and how PAR have agreed in the SAP to deal with those that dropout from the trial. That being said, the good news is that PAR have three treatment groups and one placebo group for stage 1, so people are 3x more likely to get a treatment and PAR will be able to assess the dropout rate amongst all four groups.

While i'm not 100% certain, I read the P3 trial as those who receive the placebo may need to follow the criteria for a maximum of 28 weeks, or maybe that's just for stage 2. It's a little confusing, but the secondary outcome measures imply that the Follow-up Period applies to both stage 1 and stage 2.