Tuesday, October 31, 2017 7:09:19 AM
The investigators at each of the 16 trial sites have already determined which subjects in the trial have had an incidence of grade 3 or 4 oral mucositis. The CRO that Innovation Pharmaceuticals contracted to oversee the trial knows which subjects used a Brilacidin solution and which patients used a placebo solution for their swish and spit treatment. Therefore it is readily apparent the percentage of each arm that experienced grade 3 or 4 oral mucositis.
That is also true regarding adverse side effects.
This information is readily available.
The secondary outcome measures can be released later.
https://clinicaltrials.gov/ct2/show/NCT02324335?term=NCT02324335&rank=1
Good luck and GOD bless,
George
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