It's very clear. The risk of not waiting for the signs is subjecting patients to a treatment that is not innocuous--and we have proof of this--and that could have a number of complications, without having the proof that we're actually improving their condition. Some of these complications could be serious.
We're talking about blood clotting. We're talking about internal bleeding, because in most of these patients there are thinning agents that are used as drugs before the procedure and after the procedure. In the case of a stent insertion, indeed the safety is probably even less because stents, as you know, are meant for arteries. The wall of the vein is really thinner, and the danger, of course, is that the blood flow is not as rapid and there's a danger of clotting.
All of these things are serious, and we don't have a real appreciation because it's not very common to do angioplasty of veins and to put stents into veins. We don't have a good idea of the incidence of complications and negative events. There's no question that a good clinical trial will have to include, either as a phase one or into the trial, a measurement of the safety component.