The FDA label for Lovenox, to treat VTE, was derived from clinical trials and thus the indication to treat and the duration of treatment is based on statistically significant outcomes of those trials.
What would cause the current Betrixaban clinical trial to be worthless, would be for PTLA to use a non-FDA approved treatment protocol for Lovenox because that protocol would not have been proven effective in a clinical trial.
The goal of this clinical trial is to show that Betrixaban is as effective or more effective than Lovenox at its' proven effective dosing regime.