Table 3.

Cochrane risk of bias assessment for randomized trials.

Cochrane ROB tool for RCTs	Pokorney et al. (10)	De Vriese et al. (14)
1. Sequence generation	Low—randomized	Low—computer-generated, web-based, locked central randomization system
2. Allocation Concealment	Low—randomized	Low—investigators (the investigator who reviewed all CT scans and the investigator who analyzed the pulse wave analysis curves) that were blinded to the treatment allocation
3. Blinding of participants and personnel	Low- open label with blinded event adjudication	Low—the primary endpoints were objectively measured by investigators that were blinded to the treatment allocation
4. Blinding of outcome assessors	Low—blind outcome assessment	Low—adjudication committee was blinded
5. Incomplete outcome data	Low	Low
6. Selective outcome reporting	Low	Low
7. Other sources of bias	Low	Low—although industry sponsored, all primary and secondary endpoints were adjudicated by blinded clinical events committee
Overall risk of bias	Low	Low