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This will be tested with a Cox proportional hazards model based on all participants randomized to the RCT that compares survival time (weeks from randomization to relapse) across treatment groups.
The present analysis departs from this study plan and limits observation to 12 weeks from randomization to reduce such bias.
There is a follow-up visit at three weeks from randomization, at which time the participants may have a second injection if they choose, and blood is drawn to obtain cortisol, HbA1c and fasting glucose levels.
However, the study meets its secondary end-points and showed that ambulatory levosimendan was safe and improves event-free survival by 50%% in the short term (8 weeks) and long term (24 weeks) from randomization, compared with placebo.
Restricting to outcomes beyond 12 weeks from randomization, or from 1 year, when excess disease progression/death in the CDM arm became more evident, LCM offers some benefits, but at considerable cost.
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Tumors were imaged using computed tomography or magnetic resonance imaging at baseline and at 6-week intervals from randomization until documented disease progression or initiation of a subsequent anticancer therapy.
The primary outcome measure was self-reported 2-week point prevalence abstinence at 8-week follow-up from randomization date.
The patient follow-up has three distinct phases--from randomization and baseline injection to the primary endpoint at six weeks, from optional crossover at six weeks until nine weeks, and the follow-up period from nine weeks to one year after randomization (see Figure 1).
The primary end point was the change in A1C from randomization (week 0) to week 26 to determine whether adding insulin detemir to metformin + liraglutide was superior to continued metformin + liraglutide.
Other secondary endpoints were self-reported 7-day PPA at weeks 2 and 13, self-reported CAR (weeks 26 39), total number of quit attempts from randomization through week 26, and use of smoking cessation pharmacotherapies during quit attempts.
In patients who discontinued treatment, the greatest worsening in mean SF-36 PCS scores occurred between randomization and week 2, whereas mean VAS pain scores worsened steadily from randomization to week 8.
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