Al‐Azzawi 1999.

Methods	Randomised open‐label controlled trial
Participants	235 healthy women with intact uteri, ≥ 12 months postmenopausal (mean 61 months), with serum FSH exceeding 20 IU/L. None of the women enrolled in the study had received hormone therapy during the 3 months before enrolment. Mean age: 54 years
Interventions	Tibolone 2.5 mg/d Micronised oestradiol valerate 2 mg/d + norethisterone 0.7 mg/d Administered for 1 year
Outcomes	Vaginal bleeding (0 to 3 months), menopausal symptoms, pulmonary embolism
Notes	Commented on menopausal symptoms that were assessed according to the Greene menopausal symptoms scale but provided no data on women who completed ≥ 3 months of treatment 12‐Month data on vaginal bleeding not available. Cumulative data available only for the first 3 months Timing: unclear Location: unclear (UK?) Multi‐centre: 15 sites
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not specified but, given the nature of the outcomes assessed, evaluation likely to be "objective". Open design may affect evaluation of climacteric symptoms, but these were not taken into consideration (score)
Incomplete outcome data (attrition bias) All outcomes	High risk	Number of participants analysed was variable for different outcomes and throughout the study, depending on the number of completed diaries. Cumulative 12‐month incidence of vaginal bleeding not available
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	High risk	Financed by the drug manufacturer. Study authors have conflicts of interest