Efficacy assessment
anaemia, Chronic Illness Therapy-fatigue, fatigue
ANAEMIA
Efficacy outcomes were assessed through blood sampling and questionnaire completion, which occurred at all trial visits. The primary efficacy endpoint assessed the avoidance of anaemia by determining the proportion of women with Hb ≥ 11.0 g/dL (≥ 6.8 mmol/L) at all follow-up visits during the 18-week trial period. Secondary efficacy outcomes included changes in haematological parameters (Hb, ferritin, and transferrin saturation [TSAT]) and changes in patient-reported outcomes (PROs). PROs included fatigue and quality of life (QoL), which were assessed at each visit by the official Danish versions of two self-administered generic questionnaires: the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) scale [