Item	Authors’ judgement	Support for judgement
Adequate sequence generation?	Yes	Authors were interviewed by phone and stated that a random table was used.
Allocation concealment?	Yes	Allocation concealment not mentioned in the report. Information obtained from phone interview that numbers drawn from a sealed box designated the random number allocation.
Blinding?	No	No placebo so probably not blinded.
Incomplete outcome data addressed?	Yes	7 withdrawals reported, no reason given. Four in the intervention group and 3 in the control group. Baseline data reported included participants only. No difference at baseline.
Free of selective reporting?	Unclear	No protocol provided but all nominated outcomes reported.
Free of other bias?	Yes	None identified.