- This amendment introduces that participants in the PhEAST trial may need additional chest X-Rays performed, if they are randomised to the PES treatment.
- This has been been given radiation assurance by the HRA, having had a CRE and an MPE review the new documents to ensure the correct risk assessment statements are in place.
- Further to this, this amendment introduces the collection of protocol deviations, and some additional sentences for clarifcation regarding threshold levels, and the use of catheters.
|
