Outcome Measures
The primary outcome measure was the change in daily Hot Flush Score at 12 weeks from randomisation based on the validated composite score B calculation24 (Supplementary Document 1, p49). This was calculated based on frequency and severity as recorded by participants in Sloan Diaries. The secondary outcome measures were the changes at weeks 4, 8 and 12 from randomisation in the following (1) hot flushes frequency as calculated using the frequency score B, (2) hot flushes severity as calculated using the severity score B, (3) occurrence of a response (defined as a reduction in Hot Flush Score of ≥50%) as calculated using composite score B, (4) other menopausal symptoms as measured by the Greene Climacteric Scale, (5) longitudinal QoL data as measured by the Utian QoL Scale. The trial investigated the treatment effect on outcomes in specific prognostic subgroups of healthy women versus breast or endometrial cancer survivors and BMI ≤30versus >30.