Table 2.

Adverse events

Adverse Events	FDC (n = 90)	LC (n = 90)	P-value	Odds Ratio (95% CI)
Any AE, n (%)	8 (8.9)	1 (1.1)	0.034*	8.68 (1.07–70.4)
Serious AEs, n (%)	0 (0.0)	0 (0.0)	NA	NA
Discontinuations due to AE, n (%)	0 (0.0)	0 (0.0)	NA	NA
Deaths, n (%)	0 (0.0)	0 (0.0)	NA	NA
Hypoglycemia, n (%)	0 (0.0)	0 (0.0)	NA	NA

*p-value from Fisher’s Exact Test. † All AEs were mild and resolved without sequelae. The safety population includes all participants who received at least one dose of study medication

AE = adverse event; CI = confidence interval; FDC = fixed-dose combination; LC = loose combination; NA = not applicable