I think op's point is that these people were excluded from the trial. The FDA approval does not apply for these exclusions, because they based the approval only on the inclusion criteria. There is no trial saying it's safe for people claming any one of the exclusion criteria
Reads to me like these are folks exempt from participating in trials, but I'm not well versed in this type of jibjab.
I think op's point is that these people were excluded from the trial. The FDA approval does not apply for these exclusions, because they based the approval only on the inclusion criteria. There is no trial saying it's safe for people claming any one of the exclusion criteria