Blinding
death
BLIND
Given the nature of the intervention, it is not possible to blind the participants to their intervention or those responsible for delivering the intervention (NP, SC and AD). The research assistant collecting the outcome data and the statistician will remain blind to treatment allocation (single-bind trial). Clinical outcome measures will be completed again at 8 weeks (T1), 16 weeks (T2) and 26 weeks (T3). Unblinding will be allowed only in case of a serious AE (SAE) (eg, resulting in death).