all results of the clinical trials, fully describing the results based on the efficacy criteria and end points specified in the clinical trial protocol and including the results of the statistical analyses, if appropriate;
torthaí uile na dtrialacha cliniciúla, lena dtugtar tuairisc iomlán ar na torthaí i bhfianaise na gcritéar éifeachtúlachta agus na bpointí deiridh a shonraítear sa phrótacal trialach cliniciúla agus lena n-áirítear torthaí na n-anailísí staidrimh, más iomchuí;