- AK: We did find larger number of individuals with AE. it was expected. All mild and moderate severity, all self limiting. Non of the participants in the FDC3 had to stop and not take all the doses.
- AK. Differences por zona. Some hypothesis: the main one es que en algunas zonas tienen más acceso a medicinas?
- AK. We didn't find the AE were not age sensitive. but eventhough our inclusion criteria had from 5 to 17 years old, most where 6-11. We couldn't identify any trends. In the smaller group in the phase. Tampoco para antropometric ni nada así. Lo único fue el trial site.
- JA: Site differences might mean there is site noise? from the outset, the
- JA: Site differences might mean there is site noise?
- JULIE: los programs son muy safe. The biggest safety issue is chocking.
FMS
9 months ago