. We may actually want the trial to start without the people treating the patients, or the patients, knowing what the detailed results of the preliminary study are. This may seem odd (some other member of the team or maybe a sealed brown envelope will know) but we need to try very hard to avoid anything that might flavour expectations of results because assessments of fatigue are subjective.
I know you are very limited in what you can say about the UK trial but I'll ask this anyway ....
Given your above statement Is it possible the trial might start without disclosing or publishing the results of the initial studies ?
And, if the endpoint of the trial is to demonstrate repsonders in a subset, would this mean a potentially shorter trial and follow up than Norway ?