Populations for Analysis Sample Clauses

Populations for Analysis. All analyses and data summaries will be presented for the Safety Population.

Populations for Analysis. Study Populations: Intent-to-Treat (ITT): The ITT population will include all randomized patients. Modified Intent-To-Treat (mITT): The mITT population will include all randomized patients who were culture positive for Trichomonas vaginalis and negative for other sexually transmitted infections. The primary efficacy analysis will be conducted in the mITT population. Per-Protocol (PP): The PP population will be composed of patients in the mITT population with consideration of the following criteria: received the study medication as randomized, met inclusion and exclusion criteria, had a TOC visit between Days 6-12, and had no major protocol violations. The composition of the PP population will be finalized and documented in a review of the data conducted prior to unblinding the study database. The PP population will be used for supportive efficacy analyses. Safety: The Safety population will be composed of all randomized patients who received any amount of study medication. All safety summaries will be based on the Safety population.