| Itema | Judgment |
---|---|---|
A) Sequence generation | Â | |
 | 1. Was the method of randomization adequate? | Yes / No / Unsure |
B) Allocation concealment | Â | |
 | 2. Was the treatment allocation concealed? | Yes / No / Unsure |
C) Was knowledge of the allocated interventions adequately prevented during the study? | Â | |
 | 3. Was the patient blinded to the intervention? | Yes / No / Unsure |
4. Was the care provider blinded to the intervention? | Yes / No / Unsure | |
5. Was the outcome assessor blinded to the intervention? | Yes / No / Unsure | |
D) Incomplete outcome data | Â | |
 | 6. Were incomplete outcome data adequately addressed? |  |
E) Other sources of potential bias | Â | |
7. Were all randomized participants analyzed in the group to which they were allocated? | Yes / No / Unsure | |
 | 8. Were the groups similar at baseline regarding the most important prognostic indicators? | Yes / No / Unsure |
9. Were co-interventions avoided or similar? | Yes / No / Unsure | |
10. Was the compliance acceptable in all groups? | Yes / No / Unsure | |
11. Was the timing of the outcome assessment similar in all groups? | Yes / No / Unsure |