Ann: Clinical Trial Publication Provisionally Accepted, page-30

I think the abstract tells you all you need to know.

The study is to be published in a Frontiers journal. The acceptance rate of papers in these journals is around 90% (when you pay the hefty author fee). Well conducted studies with statistically significant results that are important are never published there.

The drop-out rate of 60% in the study tells you that on an intent to treat (ITT) basis the trial would have failed. It is the ITT analysis that gets you the FDA labelling claim that NTI are seeking. Not the analysis of only those who completed.

The degree of difference between baseline and completion in the active arm is not the difference that is important at all. This simply reflects a regression to the mean effect. The fact that there may have been more regression to the mean in the active compared to the placebo simply reflects baseline differences.

In a small study like this the important difference is the difference between active and placebo at follow-up controlling for baseline.

The neuroscience blogger sphere is going to have great fun with this paper when it comes out.