

Administrative information
Open Science
Introduction
Methods
Results
Discussion
Title
Item 1a: Title stating the trial design, population, and interventions, with identification as a protocol.
Explanation
The title provides an important means of trial identification. A succinct description that conveys the topic (study population, intervention, comparator) and trial design (e.g., parallel-group randomised trial) – will facilitate retrieval from electronic database or Internet searches and rapid judgement of relevance.(28) It can also be helpful to include the trial framework (e.g., superiority, non-inferiority), objective or primary outcome, and if relevant, the study phase (e.g., phase II) and acronym.
Summary of key elements to address
Descriptive title stating:
● Trial design (e.g., parallel-group randomised trial)
● Conceptual framework (e.g., superiority, non-inferiority)
● Trial phase (if applicable)
● Population
● Intervention/comparator
● Objective or primary outcome
● “Protocol”