Table 5.

Safety analyses results using the safety analysis set

Safety outcome measure	Values		Percentage standardized difference	Estimated difference^a	95% Confidence Interval^a	P value^a
Safety outcome measure	Intervention (GKT137831) group (n = xxx)	Placebo group (n = xxx)	Percentage standardized difference	Estimated difference^a	95% Confidence Interval^a	P value^a
Treatment-emergent adverse events, n (%)
Abnormal laboratory analytes, n (%)
Abnormal physical examination and vital signs, n (%)
QT corrected electrocardiogram (ECG), mean (SD)
Treatment-emergent qualitative ECG, n (%)
Concomitant medications, n (%)
Systolic blood pressure (mmHg), mean (SD)
Diastolic blood pressure (mmHg), mean (SD)
Heart rate (beats per minute), mean (SD)
Weight (Kg), mean (SD)

SD standard deviation

^a If feasible to carry out testing; in the intervention group compared to the placebo group