| Generation of allocation sequence | 0 no double-blinding |
| 2 computer-generated random numbers | Description of withdrawals and drop-outs |
| 1 not described | 1 numbers and reasons are described |
| Allocation concealment | 0 numbers and reasons are not described |
| 3 central randomization | Efficacy of randomization |
| 2 sealed envelopes or similar | 2 pre-treatment variables in tabular from |
| 1 not described or inadequate | 1 balance of pre-treatment variables |
| Investigator blindness | 1 balance of pre-treatment variables mentioned but not in tabular form |
| 2 identical placebo tables or similar | 0 no information report |
| 1 inadequate or not described |