Forty-eight men were enrolled in the trial (the intent-to-treat population), but four men had testosterone levels >350 ng/dL at baseline.
In each trial, the intent-to-treat (ITT) population included all randomised subjects with wild-type KRAS mCRC, regardless of treatment received.
Dense regulations and multitiered review processes accompany every clinical trial, with the intent of ensuring protection of human subjects.
The INTENT trial is a single-centre, single-blind, randomised controlled trial with outcomes assessment blinded to group allocations.
The INTENT trial will provide important data on the effectiveness of nutrition interventions to prevent excessive weight gain after transplantation.
The INTENT trial will thus provide important data on the effect of intensive nutrition interventions on weight gain after transplant and the associated metabolic consequences.
This trial was designed with the intent to administer high levels of Lu-IMP288 using dosimetry to predict a safe dose.
The primary aim of the INTENT trial is to determine whether the use of an intensive nutrition intervention, including physical activity advice, following kidney transplantation will be effective at reducing weight gain in the first year post-transplant.
In a randomized, double blind, placebo-controlled phase II/III efficacy clinical trial in advanced NSCLC the intent to treat analysis (ITT) showed a statistically significant benefit in overall survival for the Racotumomab arm.
The INTENT trial will be used to assess the feasibility of undertaking a larger study to determine if nutrition interventions early after kidney transplant can reduce the incidence and severity of diabetes after transplantation (and thus potentially the risk of cardiovascular events).
But an assistant district attorney, Karen E. Antoine, argued during the trial that intent was less important than the fact that Mr. De La Vega did not have permission to paint on the side of the building.
