Measures to Minimize Bias Sample Clauses

Measures to Minimize Bias. Randomization and Blinding Single-blind (Run-in only) and double-blind (Treatment Period) techniques will be used. Vibegron and its matched placebo will be packaged identically so that the treatment blind is maintained. The subject, Investigator, and Sponsor personnel or delegate(s) who are involved in the treatment or clinical evaluation of the subjects will be unaware of the treatment group assignments during the double-blind Treatment Period. Subjects will be centrally assigned to randomized study drug using an interactive web response system (IWRS) and the randomization schedule generated by the Sponsor or designee. Before the screening is initiated at each site, login information and directions for the IWRS will be provided. The IWRS will be programmed with blind-breaking instructions. In case of an emergency, the Investigator has the sole responsibility for determining if unblinding of a subject’s study drug assignment is warranted. Subject safety must always be the first consideration in making such a determination. If the Investigator decides that unblinding is warranted, the Investigator should make every effort to contact the Sponsor or designee prior to unblinding a subject’s study drug assignment unless this could delay emergency treatment of the subject. If a subject’s study drug assignment is unblinded, the Sponsor or designee must be notified within 24 hours after breaking the blind. The date and reason that the blind was broken must be recorded in the source documentation. At the end of the study, the official, final database will be frozen and unblinded after medical/scientific review has been performed, and data have been declared final and complete. The Sponsor will be granted access to the unblinded database in order to analyze the data. A clinical study report will be prepared after all subjects complete the study.‌‌‌
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Measures to Minimize Bias. Randomization and Blinding
Measures to Minimize Bias. RANDOMIZATION AND MASKING This Phase I study will not include randomization or masking.

Related to Measures to Minimize Bias

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