There has been some "relaxation" of the rules regarding the various phase trial sample sizes and trial time lengths.
Clearly there is a risk/reward analysis here.
I'm not saying corners have been cut but they have been rounded.
I know for a fact some of the trials had trouble getting enough people of certain ethnic groups to take part.
Considering some of those groups are disproportionately effected it has raised some questions.
Overall I think a fabulous job has been done both practically and ethically.
The worst and most common side effect looks to be pain at point of injection lasting 1-3 days...
Posted By: usacanary, Dec 2, 16:22:44
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