Statement: numerous incidences were reported of congestive heart failure in both cohorts of the primary clinical trial.
Primary_evidence: Adverse Events 1:   Total: 1/35 (2.86%)   congestive heart failure *1/35 (2.86%) Adverse Events 2:   Total: 0/40 (0.00%)   congestive heart failure *0/40 (0.00%)