Sentence examples for interventions will be reported from inspiring English sources
Direct and indirect costs of the interventions will be reported.
All SAEs causally related to trial interventions will be reported to the sponsor and to the relevant oversight bodies, and will be followed until they resolve or stabilise.
Any SAE considered to be related to the trial procedures or interventions will be reported to the main Research Ethics Committee by the Chief Investigator within 15 days of her becoming aware of the event.
▪ Co-interventions: In both groups, any co-intervention will be reported in the cost-diaries.
The intervention will be reported using the Template for Intervention Description and Replication (TIDieR).
Intervention group and counselor satisfaction with the intervention will be reported descriptively.
The data together with any other spontaneously reported adverse events during the intervention will be reported.
The trial and intervention will be reported according to CONSORT and TIDieR guidelines.
The development and pilot-testing of the intervention will be reported separately in detail.
Outcomes of the intervention will be reported in a future paper.
