Statistical analysis
REGRESSION
Linear regression models were used for contrasting change in mean scores for the 20 mg dose arm versus the placebo arm to identify symptoms and anthropometric measures associated with the standard dose of tamoxifen. Similar regression models were employed in the dose dependency analyses, where we estimated the association between change in mean scores and dose arms, limited to the symptoms identified to be significantly associated with tamoxifen. In contrast to the analysis where tamoxifen-associated symptoms were identified using placebo as a reference, we presented the dose-dependent results using the 20 mg group for comparison, to test how intensity was affected by lower doses compared to standard dose treatment in a clinical setting. Every dose was contrasted to the 20 mg arm and in addition the association between higher dose and severity change was tested using linear regression analysis with actual dose (0, 1, 2.5, 5, 10 and 20 mg) as independent variable.We further computed a score of the identified top five symptoms by summing means of Likert score change from baseline to end of treatment. Linear regression was used to contrast low-dose vs high-dose tamoxifen stratified by menopausal status. In the same manner, increase in Likert scores was calculated and categorised to ≥1, ≥2, ≥3, ≥4 and ≥5 Likert score. Logistic regression was used to compare differences in proportion of women increasing by categories, stratified by menopausal status and tamoxifen dose.All calculations were performed on the per protocol population and stratified on menopausal status. Wald tests were performed for testing associations and possible interactions by menopausal status. All 