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 |