Overview
SD
Figure CONSORT 2010 Flow Diagram. Note: ITT – Intention to treat; PP – Per protocol. *One participant was randomized to the wrong group but also had missing primary outcome as well and was therefore reported in the missing outcome numbersTwo participants had a major protocol violation after randomization and were excluded from analysis. One participant had a baseline BMI below the < 28 kg/mParticipants were predominantly New Zealand European, with a mean age of 45.7 years (SD 8.7) years. The two groups were comparable at baseline (Table Participant baseline demographic and study site data (Note: Data presented from participants recruited in waves one and two only