Values with CTC grade as 3 or above will be flagged in the listings. 8.3.3 Vital Signs Vital sign s are composed of systolic/dia stolic blood pressure, respiratory rate, heart rate, and body temperature . Summary statistics for baseline, each post -baseline measurement, and change from baseline for each post -baseline measurement will be presented for each treatment arm and overall , by each vital sign parameter . Baseline is defined as the pre dose observation value of each dosing visit. Also all vital sign values will be listed in data listing s. 8.3.4 ECG ECG absolute individual parameters and the change from baseline will be summarized by treatment arm and overall per assessment as continuous measurements. QTc and maximum QTc (including change s from baseline ) will be summarized as both continuous and categorical measurements, where the cate goric al for QTc , and change from baseline QTc are as follows, respectively: o Observed post baseline value : >450- ≤480; >480- ≤500 and >500 (msec) o Change from baseline: >30- ≤60 and >60 (msec) All ECG measurements will be presented in data listings. 8.3.5 Physical Findings Physical examination results will be presented in a listing, including screening and each post treatment visit.