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Based on our tentative calculations, a total of eighteen clinics will be randomized equally to intervention and control groups.
Distressed breast cancer survivors will be randomized equally to one of two groups: (a) P-OSG, a facilitated OSG with structured helping opportunities and coaching on how to recognize and be responsive to others needs for help or (b) S-OSG, a comparison standard facilitated OSG.
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Study Design: A total of 142 patients were randomized equally to receive one of the two grafts after meeting all eligibility requirements.
Fifty-two patients were randomized equally to either CPAP + standard of care (nCPAP group) or to standard of care (standard group) for acute undifferentiated SOB.
The patients were randomized equally to receive subcutaneous injections of placebo every 2 weeks for weeks 0 10 and sirukumab 100 mg every 2 weeks for weeks 12 24, or sirukumab 25, 50, or 100 mg every 4 weeks, or 100 mg every 2 weeks for weeks 0 24.
At this point, approximately 690 patients had been randomized and eligible patients completing the run-in phase were randomized equally between the EVR+Reduced TAC and TAC Control groups.
In the intent-to-treat population, 104 patients were randomized equally between the eribulin and ixabepilone groups.
Of the 54 patients who were screened, 30 were eligible for the study and were randomized equally between the two treatment groups.
Patients were randomized equally (1 1 1) to receive intravenous infusions of infliximab at 5 mg/kg or 10 mg/kg, or placebo at weeks 0, 2, and 6, and then every 8 weeks through week 22 in ACT 2 or week 46 in ACT 1. Patients were followed for PK and immune response purposes through week 42 in ACT 2 and week 54 in ACT 1.
Initially, 150 volunteers were recruited to the study and these were randomized equally either into the test or into the control group through block randomization.
Since the multiple scattered light is randomized polarized, contributing equally to channel 1 and 2, the subtraction of channel 1 from channel 2 can eliminate the effect of backscattered photons and filter superficial backscattered photons.
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