PaS2-EXTEND Clinical Trial

Progression to a definitive trial is considered appropriate only if all four primary feasibility criteria are met. The trial adheres to SPIRIT 2025 guidelines and the CONSORT extension for pilot and feasibility trials. A sample size of 24 participants (12 per group) provides 80% power to detect moderate-to-large effect sizes in repeated-measures analyses with two groups and three time points. PaS2-EXTEND is a prospective, randomised, multisite, assessor-blinded, active-comparator-controlled, two-arm parallel-group pilot feasibility trial. Patient representatives from UNIAMO-FIMR participated in three structured consultation meetings during the design phase, resulting in three substantive protocol modifications. De-identified individual participant data will be made publicly available 6 months after publication of primary outcomes, subject to a signed data use agreement and ethics documentation.