TABLE 6.

Adverse events.

	PEMA (n = 63)	OMEGA-3 (n = 63)
AEs	9 (14.3)	3 (4.8)
Participants who discontinued treatment because of drug-related AE
Nausea	1 (1.6)	0 (0.0)
Pain in the  extremities	1 (1.6)	0 (0.0)
Erythema on the  forearm	1 (1.6)	0 (0.0)
Itching in the  forearm	1 (1.6)	0 (0.0)
General malaise	1 (1.6)	0 (0.0)
Anorexia	1 (1.6)	0 (0.0)
Participants who discontinued treatment because of drug-unrelated AE
Neck stiffness	1 (1.6)	0 (0.0)
Tooth pain	1 (1.6)	0 (0.0)
Sepsis associated  with enteritis	1 (1.6)	0 (0.0)
Other AEs
Worsening of  glycemic control	2 (3.2)	1 (1.6)
Acute epiglottitis	1 (1.6)	0 (0.0)
Dental caries	1 (1.6)	0 (0.0)
Liver dysfunction	1 (1.6)	0 (0.0)
Muscular pain	1 (1.6)	0 (0.0)
Fall	0 (0.0)	1 (1.6)
Lumbago	0 (0.0)	1 (1.6)
Elevation of serum  CK	0 (0.0)	1 (1.6)

The data are presented as n (%). AE, adverse event; CK, creatine kinase.