Common use of Treatment Assignment Clause in Contracts

Treatment Assignment. All patients who are screened for the study will be assigned a unique 7 digit patient number which will be used to identify patients throughout the study and on the CRFs. Patient numbers will be assigned as follows: XXX YYYY, where: · XXX represents the study site number; · YYYY represents the patient ID number Patients who meet all inclusion criteria and none of the exclusion criteria and successfully complete the Screening and Pretreatment Periods of the study will be assigned sequentially to a randomized treatment group on Day 1 of the Treatment Period. Patients will only receive one study ID at the time of screening and therefore will not receive a new identifier at randomization. During the randomization call, sites will enter the kit number assigned to the subject into the IVRS system. The IVRS system will record the site number, the subject number and the kit/randomization number within the system. Information regarding treatment assignment will reside within the IVRS system, as part of the study blinding. Study medication kits will be assigned sequential numbers beginning with 001. The study medication kit number assigned to an eligible patient will be recorded in the source documents, on the appropriate page of the CRF, and reported to the IVRS system as described above. Once a kit has been assigned, it may not be reused. The Sponsor statistician will be responsible for overseeing the preparation of the master randomization scheme that will be used to package study medication into kits and for the IVRS system.