CONSORT requirements

Information on randomisation required in the CONSORT statement*

• Sequence generation (Item no. 8): Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification).
• Allocation concealment (Item no. 9): Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.
• Implementation (Item no. 10): Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.