| 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 |
Possible biased follow‐up and reporting bias |
| Summary assessments |
Low risk |
Plausible bias unlikely to seriously alter the results. |
