| Random sequence production |
| a. Adequate (computer generated random numbers or similar methods) (2 points) |
| b. Unclear (a randomized trial but without description of randomization methods) (1 point) |
| c. Inadequate (an alternative allocation without randomization) (0 point) |
| Allocation concealment |
| a. Adequate (a central institution-controlled allocation) (2 points) |
| b. Unclear (random numerical table or other similar methods) (1 point) |
| c. Inadequate (alternative allocation without adequate concealment) (0 point) |
| Blindness |
| a. Adequate (comparable placebo or similar methods) (2 points) |
| b. Unclear (a blind trial without details statement) (1 point) |
| c. Inadequate (inappropriate blind methods or non-blind trials) (0 point) |
| Withdrawal |
| a. Description (a detailed statement about the numbers and reasons of withdrawals) (1 point) |
| b. No description (no statement about the numbers and reasons of withdrawals) (0 point) |
