MacPhail 1996b.

Methods	Same as MacPhail 1996
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random allocation, does not mention method used to generate allocation sequence
Allocation concealment?	High risk	Not reported
Blinding? All outcomes	Low risk	Double blind. Participant and investigators blinded.
Incomplete outcome data addressed? All outcomes	High risk	34% loss to follow‐up in stratum 1. No ITT,