Randomisation
A sequence for random allocation of patients to the 3 treatment groups was generated by an isolated biostatistician within the organization responsible for study management. The PLAN procedure provided in the statistical software package SAS version 9.4 was used with block size of 6. Prospective concealment of the sequence was achieved using the envelope method. Patients were enrolled separately at each study site, and interventions were assigned to patients by an investigator at each site on the basis of the assignment revealed on opening envelopes in sequence at the time of patient enrolment.