Trial data submissionHow possible is it that the FDA would accept those data to be submitted for approval supposing they have a minimum requirement of 5% MB, take into account the unusual placebo group, and then "fix" the sample size to reflect those patients with up to 18% MB if that is the case? Any possibility in your opinion that observational or whatever follow-up studies could be done once the marketing approval has been granted? Any similar scenario that can be found in the FDA history?