| Study population | | | |
| D1 | Was a method of randomisation performed? | | | |
| D2 | Was the allocation of treatment concealed? | | | |
| D3 | Were the groups similar at baseline regarding the most important prognostic indicators (age, sex, disease duration, disease severity)? | | | |
| D4 | Were both inclusion and exclusion criteria specified? | | | |
| Blinding |
| D5 | Was the outcome assessor blinded? | | | |
| D6 | Was the care provider blinded? | | | |
| D7 | Was the patient blinded? | | | |
| Analysis |
| D8 | Were point estimates and measures of variability presented for the primary outcome measures? | | | |
| D9 | Did the analysis include an intention-to-treat analysis? | | | |
| D10 | Is the withdrawal/drop-out rate <20% and equally distributed? | | | |