Economic evaluation
The economic evaluation consisted of a cost-utility analysis (CUA) and a cost-effectiveness analysis (CEA) from a societal perspective with the costs per quality adjusted life year (QALY) and the costs per point functional outcome improvement as the primary economic outcomes. The costs were also compared to the willingness to pay. Both direct and indirect costs were used, based on average unit costs of 2018. The analyses were based on the intention-to-treat groups, using a time horizon of 12 months, since relevant differences in outcome and health care costs were expected to occur within that period.