Outlier results in a Clinical TrialBy any objective observation the placebo results are an outlier. The FDA has a procedure to address these circumstances. It can be found in the
Statistical Principles for Clinical Trials The pertinent info states:
If no procedure for dealing with outliers was foreseen in the trial protocol, one analysis with the actual values and at least one other analysis eliminating or reducing the outlier effect should be performed and differences between their results discussed.
Very confident the cause of the outlier will be identified and the analysis performed with the outlier effect eliminated will provide ample data for the FDA.