Treatment Assignment. All subjects who participate will continue to be identified by the same 7-digit subject number that was assigned upon enrollment into Study BA058-05-003 throughout the study and on the eCRF.
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 Attachment 2, Attachment E-37 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.
Treatment Assignment. Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Randomization will be performed using an interactive web response system (IWRS). Patients randomized to placebo will remain on placebo throughout the study, but will follow sham titration to maintain the blind.
Treatment Assignment. This is a double-blind study. Eligible subjects will be randomly assigned to receive SAGE-217 or matched placebo on a 1:1 basis. Subjects, clinicians, and study team will be blinded to treatment allocation. Dose adjustments will only be allowed as described in Section 9.3.
Treatment Assignment. After providing informed consent at the baseline visit, the subjects will be randomly allocated to either active snus or placebo snus. Stratification will be made according to treatment centre. Randomization will be done by telephone to a central office where participant’s identifiers are recorded. The random allocation will be done according to a computer-based algorithm.
Treatment Assignment. All patients enrolled in this cohort will receive TSR-042, bevacizumab, and niraparib as indicated in Figure 1.
Treatment Assignment. This is an open-label study.
Treatment Assignment. Three dose levels will be administered by a single i.vt. injection in the study eye as noted in Table 1. Table 1: Dose Groups and Associated RBM-007 Concentration Dose Group RBM-007 Concentration Cohort 1: 0.2 mg 100 microliters of 2 mg/mL RBM-007 Cohort 2: 1.0 mg 50 microliters of 20 mg/mL RBM-007 Cohort 3: 2.0 mg 100 microliters of 20 mg/mL RBM-007
Treatment Assignment. All patients will receive LJPC-501 in this single-arm, open-label study.
Treatment Assignment. Participants will be randomly assigned to a treatment group on Day 1 and will be stratified based on use of antidepressant treatment (current/stable or not treated/withdrawn ≥30 days or >5 half-lives) at baseline. Randomization will be performed within each stratum in a 1:1 ratio to receive SAGE-217 50 mg or matching placebo. Additional details on randomization and blinding are provided in Section 9.5.
