TABLE 2.

Adverse events in safety analysis set during trial.

	Intervention group (n = 223)	Control group (n = 224)
All adverse events	128	90
At least one serious adverse event	83 (37%)	65 (29%)
Blood and lymphatic system disorders	0 (0%)	1 (<1%)
Cardiac disorders	7 (3%)	4 (2%)
Ear and labyrinth disorders	3 (1%)	0 (0%)
Endocrine disorders	1 (<1%)	0 (0%)
Eye disorders	15 (7%)	17 (8%)
Gastrointestinal disorders	7 (3%)	7 (3%)
General disorders and administration site conditions	0 (0%)	1 (<1%)
Infections and infestations	8 (4%)	3 (1%)
Injury, poisoning, and procedural complications	18 (8%)	15 (7%)
Investigations	4 (2%)	1 (<1%)
Metabolism and nutrition disorders	3 (1%)	5 (2%)
Musculoskeletal and connective tissue disorders	13 (6%)	5 (2%)
Neoplasms: benign, malignant, and unspecified	15 (7%)	15 (7%)
Nervous system disorders	9 (4%)	6 (3%)
Renal and urinary disorders	1 (<1%)	2 (1%)
Reproductive system and breast disorders	0 (0%)	1 (<1%)
Respiratory, thoracic, and mediastinal disorders	2 (1%)	2 (1%)
Skin and subcutaneous tissue disorders	2 (1%)	0 (0%)
Vascular disorders	3 (1%)	0 (0%)
Unspecified	2 (1%)	0 (0%)