Item	Authors’ judgement	Support for judgement
Adequate sequence generation?	Yes	SAS was used to generate the allocation sequence.
Allocation concealment?	Yes	Both the participant and the intervention provider did not know the allocation groups.
Blinding?	Yes	Participants, doctor and outcomes assessor all blinded.
Incomplete outcome data addressed?	Yes	All participant data reported. 5 withdrawals.
Free of selective reporting?	Unclear	No protocol reported but all expected and nominated outcome measures were reported.
Free of other bias?	Yes	None identified.