Table 11 Serious Adverse Events Summary

All participants

279

281

560

Participants without serious adverse events

278

278

556

All adverse events

98

114

212

All serious adverse events

2

4

6

 Cerebrovascular accident

0 (0.0%)

1 (0.9%)

1 (0.5%)

 Coronary artery disease

1 (1.0%)

0 (0.0%)

1 (0.5%)

 Fall

0 (0.0%)

1 (0.9%)

1 (0.5%)

 Myocardial infarction

1 (1.0%)

0 (1.0%)

1 (0.5%)

 Pulmonary embolism

0 (0.0%)

1 (0.9%)

1 (0.5%)

 Urosepsis

0 (0.0%)

1 (0.0%)

1 (0.5%)