Primary outcome measures–assessment of progression criteria against predefined targets
ADVERSE REACTION, RECRUITMENT
All individuals considered eligible after screening consented to participate, exceeding the target of 50%. The average recruitment rate was 2.9 per month over 18 months, exceeding the target of 2 per month. Participant retention was 45/53 (85%, 95% CI (72%, 93%)) and 44/53 (83%, 95%CI (70%, 92%)) by weeks 48 and 96, respectively, exceeding the target of 65%. At weeks 48 / 96, data completeness was 94% / 96% respectively, exceeding the target of 80%. There were no Serious Adverse Reactions, with 5/23 (22%, 95% CI (5%, 49%)) participants reporting AR by week 48 and no new AR by week 96 (