Item	Orsulic‐Jeras 2000
Inclusion/exclusion criteria for participants clearly defined	No*
Reporting of all relevant characteristics of the participants	Yes
Absence of relevant differences between groups after randomisation	Yes*
Adequate sample size calculation	No*
Loss to follow‐up less 5% of participants	No
Were incomplete data adequately explained	Yes
All groups treated equally, except of intervention or control	Yes
Primary outcome clearly stated?	No
Participants blinded to group allocation	No
Personnel blinded to group allocation	No
Outcome assessors blinded to group allocation	No
Intention to treat analysis	Yes*
Complete reporting of outcome (as scheduled)	Yes
Conflicts of interest mentioned	No
* Items marked with an asterisk have been answered by the study authors after personal request