Certainly is interesting. How can you structure a trial with a placebo if this is the case?
It appears that the AEs are tolerable / non-serious
Unless you can assume the participants are ignorant to the signs, or find something other that saline that produces a similar AE to PPS, but I can't see that as an option as it has its own issues.
There must be precedent for this issue and how to handle it?
Either way, the drug works and people are going to want to stick this in their body. ( My opinion of course )
research reports and media, page-1547
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