Treatment allocation Clause Samples
Treatment allocation. This is an open label study. All patients will be treated with BL-1040. Patient eligibility will be established prior to treatment with BL-1040. If a patient discontinues from the study, the patient number will not be reused.
Treatment allocation. Random treatment allocation was at the level of the primary care surgery, which was done partly to avoid treatment contamination that was anticipated if a nurse were asked to provide both control and active treatments. Other reasons for using cluster randomisation included variations in local demographics and healthcare delivery, and preventing a feeling of unfairness within surgeries (which might have led to patients seeking out the treatment). Treatment assignment was in the ratio 1:1 and was done in two phases. Treatment allocation was revealed to the trial manager after practice details were entered. The intention was for randomisation to take place after all patients had been recruited but this led to unacceptable delays in the training of nurses. This meant that some patients were recruited after randomisation of surgeries but were kept blind to allocation until the interventions were offered in both groups. Assessors remained blind to treatment allocation until after baseline data had been collected.