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Item 1: Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym.


“A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol®  Therapy QD [once daily] Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis.” 19


The title provides an important means of trial identification. A succinct description that conveys the topic (study population, interventions), acronym (if any), and basic study design – including the method of intervention allocation (e.g., parallel-group randomised trial; single-group trial) – will facilitate retrieval from literature or Internet searches and rapid judgment of relevance.20 It can also be helpful to include the trial framework (e.g., superiority, non-inferiority), study objective or primary outcome, and if relevant, the study phase (e.g., phase II).

2a: Registry