Randomization. The Manufacturing Computer shall utilize randomizing procedures in the creation of the subsets. The randomizing procedures shall be in accordance with Section 6.0 of this Appendix.
Randomization. Each work period, the random lists shall be compiled by placing each eligible employee’s name into a selection device. Once all names have been deposited, they shall be mixed. After mixing is complete, each name shall be selected one at a time by the Superintendent or his designee. The first name selected shall be placed on the top of the work assignment list, and so forth.
Randomization. Long-term effectiveness of computer-generated tailored patient education 1 month 12 months 1 month Randomization Chapter 5 Recruitment Long-term effectiveness of computer-generated tailored patient education 63 The tailored intervention
Randomization. The trial coordinator will assign the participant a Subject Number from one to 50, in sequential order. (The first patient enrolled is assigned #1, the second enrolled is assigned #2, and so on.) The trial coordinator will then randomize the patient to either the Control Group or the Device Group using a randomization matrix generated by a computer randomization program. Data Collection. The trial coordinator will inform two trained providers that the patient has agreed to participate in the trial. The trial coordinator will accompany one hospital provider to the patient’s hospital room. The second provider will wait outside the room, in a place where s/he cannot hear the interaction in the room. The trial coordinator will re-affirm consent with the patient.
Randomization. Licensed establishments will be selected for field evaluation based on random selection methodologies detailed in the FDA Audit Manual (Draft), June 30th, 2004. Random selection of licensed establishments will follow the protocol described in the Randomization Procedure (Appendix F). The random selection will be conducted onsite the first day of the evaluation.
Randomization. A complete randomization scheme will be applied with a 1 levosimendan : 1 placebo allocation ratio. The complete randomization scheme will eliminate the possible bias due to predictability of treatment assignment.58
Randomization. Randomization is designed to maintain blinding of the patient, the PI, the local PI, paramedics, local study staff, local allied health personnel, the Clinical Coordinating Center, and the Data Management Center (DMC). Xx. Xxxxxxxx, the chief study statistician at the DMC, will generate the randomization algorithm for the study and will be unblinded. Study drug will be prepared according to a prearranged randomization assignment developed by Xx. Xxxxxxxx. Randomization will be in permuted block design allocating magnesium sulfate or placebo in a 1:1 ratio, and will be stratified within each rescue vehicle by elapsed time from stroke symptom onset (15-60 minutes, 61-120 minutes). A general study goal is to enroll a substantial number of patients in each of the < 1 hour from onset and 1-2 hr from onset strata. The proportion of patients enrolled in each strata will be continuously monitored by the DMC. If the proportion of patients enrolled in one strata exceeds 70%, enrollment in that strata may be placed on hold studywide until enrollment in the other strata exceeds 31%.
Randomization. All patients enrolled in the Phase 2 portion will be assigned to bardoxolone methyl. An IWRS will be utilized to randomize Phase 3 patients 1:1 to bardoxolone methyl or placebo. Randomization will be stratified by screening albumin to creatinine ratio (ACR) using the following categories: (1) ACR ≤ 300 mg/g; (2) 300 mg/g < ACR ≤ 1000, (3) ACR > 1000 mg/g.
Randomization. You will be assigned to a treatment program by chance, and the treatment you receive may not work as well or have more side effects than the other study treatment(s) or other available treatments. Washout period: You [will/may] receive no medication, or medication at a dose which may not help your condition. As a result, you [will/may] have an increase in symptoms including [XX].
Randomization. This is an open-label, non-randomized study.
