Table 1.

Description of studies used in the analysis

Study		Description of study	N (number of subjects)	Treatment	ECG extraction and time-matched PK sample
TQT		Three-way crossover, placebo-controlled study	60	Placebo, 25 and 250 mg	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, and 24 h
Phase I	SAD	Parallel group, dose escalating study	28	Placebo, 25, 50, 100, and 200 mg	Short Tmax:0, 1, 2, 4, 8, and 24 h Intermediate Tmax: 0, 1.5, 3, 6, 12, and 24 h Long Tmax: 0, 3, 6, 9, 12, and 24 h
	MAD	Parallel group, dose escalating study	28	Placebo, 20, 40, 60, and 80 mg	Short Tmax: 0, 1, and 2 h on day 1, 3, and 6. Intermediate Tmax: 0, 1.5, and 3 h on day 1, 3, and 6. Long Tmax: 0, 3, and 6 h on day 1, 3, and 6.
Phase I + day 0	SAD	Parallel group, baseline-controlled, dose escalating study	28	Placebo, 25, 50, 100, and 200 mg	Short Tmax:0, 1, 2, 4, 8, and 24 h on day 0 and 1 Intermediate Tmax: 0, 1.5, 3, 6, 12, and 24 h on day 0 and 1 Long Tmax: 0, 3, 6, 9, 12, and 24 h on day 0 and 1
	MAD	Parallel group, baseline-controlled, dose escalating study	28	Placebo, 20, 40, 60, and 80 mg	Short Tmax: 0, 1, and 2 h on day 0, 1, 3, and 6. Intermediate Tmax: 0, 1.5, and 3 h on day 0, 1, 3, and 6. Long Tmax: 0, 3, and 6 h on day 0, 1, 3, and 6.