As the primary efficacy outcomes, the following were compared between the two groups from baseline up to day 28 post-randomisation: (1) overall 28-day mortality, (2) clinical status on study day 28, using an 8-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020) 0 for uninfected, 1 for no limitation of activities (ambulatory), 2 for limitation of activities (ambulatory), 3 for hospitalised, no oxygen therapy (hospitalised mild disease), 4 for hospitalised, oxygen by mask or nasal prongs (hospitalised mild disease), 5 for hospitalised, noninvasive ventilation or high-flow oxygen (hospitalised severe disease), 6 for hospitalised, intubation and mechanical ventilation (hospitalised severe disease), 7 for hospitalised, ventilation plus additional organ support, pressors, renal replacement therapy, and ECMO (extracorporeal membrane oxygenation), and 8 = death, and proportion of patients who met recovery criteria which are defined with the WHO clinical status 1, 2, or 3

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Seek emergency care (call 999) if hot flushes are accompanied by severe allergic reaction symptoms, severe persistent abdominal pain suggesting pancreatitis, chest pain, difficulty breathing, or signs of severe hypoglycaemia with loss of consciousness
Miholjcic TBS, Halse H, Bonvalet M, Bigorgne A, Rouanne M, Dercle L, et al