| Was the assigned treatment adequately concealed prior to allocation? |
1 |
1 |
2 |
2 |
2 |
1 |
| Were the outcomes of participants who withdrew described and included in the analysis? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were the treatment and control group comparable at entry? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were the outcome assessors blinded to treatment status? |
2 |
0 |
2 |
0 |
0 |
0 |
| Were the participants blind to assignment status after allocation? |
0 |
0 |
0 |
0 |
0 |
0 |
| Were the treatment providers blind to assignment status? |
0 |
0 |
0 |
0 |
0 |
0 |
| Were care programs, other than the trial options, identical? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were the inclusion and exclusion criteria clearly defined? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were the interventions clearly defined? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were the outcome measures used clearly defined? |
2 |
2 |
2 |
2 |
2 |
2 |
| Were diagnostic tests used in outcome assessment clinically useful? |
2 |
2 |
2 |
2 |
2 |
2 |
| Was the surveillance active, and of clinically appropriate duration? |
2 |
2 |
2 |
2 |
2 |
2 |
