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?:definition
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A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. EXAMPLE(S): To extend the life of study participants by at least 3 years. To determine efficacy of Drug X dose 1, dose 2, and dose 3 as measured by the percentage of subjects experiencing headache relief. To compare overall survival in subjects with [type of cancer] who have received [prior treatment] and who are randomized to treatment with either Combination A+B or single-agent B. To select a Drug X dose for further evaluation based on comparison of the short-term antiviral activity, safety, and tolerability of different oral doses of Drug X in combination with Drug Y in HIV-1 infected therapy-naive subjects. To compare the proportion of subjects developing a rash in subjects administered dermatological precautions (DP) versus subjects administered usual care precautions (UC) during 12 weeks of treatment of Drug X in [disease description] subjects. To obtain exploratory descriptive information on the relationship of tobacco use, alcohol use and dietary patterns on toxicity and outcomes in males and females. OTHER NAME(S): NOTE(S): StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms).
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