| Was the study described as randomised? | 1 |
| Was the method used to generate the sequence of randomisation described and appropriate (random numbers, computer-generated, etc)? | 1 |
| Was the study described as double-blind? | 1 |
| Was the method of double-blinding described and appropriate (identical placebo, active placebo, dummy, etc)? | 1 |
| Was there a description of withdrawals and drop-outs? | 1 |
| Deduct one point if method used to generate sequence of randomisation described, but inappropriate (allocated alternately, or according to date of birth, or hospital number) | −1 |
| Deduct one point if study described as double-blind, but method of blinding inappropriate | −1 |