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4.2. Secondary analysis
To identify any longer term effects of KY02111 intervention on symptoms, repeated measures mixed modelling of hot flushes/night sweats will be undertaken to compare groups across all time points, adjusting for covariates and multiple comparisons as previously described.
Secondary outcomes including the hot flushes/night sweats, quality of life, subjective vitality, depression/anxiety, self-efficacy for exercise and physical activity (objective and self-report) will also be compared at the six and 12 month follow-up using the same method. The frequency, intensity, type and duration of exercise will be summarised in MET/min. Bland–Altman plots will be used to compare the physical activity measured by the IPAQ with that measured objectively by the actiheart. The number of participants achieving varying thresholds of physical activity at follow-up will be documented according to BMI and menopausal status in both intervention groups. The number of adverse events that occur during the intervention period will be summarised by group.