Assessment

1. a) Were the patients assigned randomly? 1 = Yes 0 = No b) Randomization adequately described? 2 = Yes 1 = Partly 0 = No c) Was treatment group concealed to investigator? 1 = Yes 0 = No

2. a) Description of outcome measurement adequate? 1 = Yes 0 = No b) Outcome measurements objective? 2 = Yes 1 = Partly 0 = No c) Were the assessors blind to treatment? 1 = Yes 0 = No

3. a) Were inclusion /exclusion criteria well defined? 2 = Yes 1 = Partly 0 = No b) Number of patients excluded and reason? 2 = Yes 1 = Partly 0 = No

4. a) Was the therapy fully described for the treatment group? 2 = Yes 1 = Partly 0 = No b) Was the therapy fully described for the controls? 2 = Yes 1 = Partly 0 = No

5. a) Was the test stated and was there a P value? 1 = Yes 0 = No b) Was the statistical analysis appropriate? 2 = Yes 1 = Partly 0 = No c) If the trial was negative, were confidence intervals or post hoc power calculations performed? 1 = Yes 0 = No d) Sample size calculation before the study? 1 = Yes 0 = No