Fig. 1

Schedule of participant enrolment, interventions and assessments in the trial. 1. All screening assessments are part of routine clinical practice. 2. Weekly visits are recommended but not mandatory; normal hospital clinical practice is acceptable. 3. No other trial-specific procedures are required before consent. 4. These blood tests are taken as per routine clinical practice and are not trial specific. 5. Investigational Medicinal Product (IMP) started after randomisation. IMP dose altered by the research team if indicated by symptoms and/or blood tests taken during normal clinical practice. 6. Cardiotocography only measured 1 week after randomisation or as per routine clinical practice. 7. All unexpected adverse events occurring during the trial that are observed by the research team or reported by the participant will be recorded in the electronic Case Report Form, whether or not attributed to the IMP. Unexpected serious adverse events will be expeditiously reported. 8. All prescribed medications deemed necessary by the investigator to provide adequate supportive care for ICP are permitted during the clinical trial. The medications must be recorded in the participant’s electronic Case Report Form; all other concomitant medication will only be recorded in the event that a serious adverse event is reported