| Methods | see Tam 2007a (year 2) | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Funding Source | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number |
| Allocation concealment (selection bias) | Low risk | "At enrolment, each subject was assigned the next sequential subject number and received study product of the treatment code assigned to that subject number according to a preprinted randomisation allocation list" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Possibility of biased follow‐up and reporting bias |
| Summary assessments | Low risk | Plausible bias unlikely to seriously alter the results |