Nil minimum screening rate |
Greater than or equal to 80% of eligible participants will agree to enrol |
Greater than 80% of participants in the intervention groups will receive their allocated treatment (measured twice weekly whilst participant recruited to study) |
Less than 10% of data collection for primary outcomes will be missing |
Less than or equal to 40% of participants will be lost to follow-up, withdraw from the study or be deemed ineligible after they have commenced treatment |