Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from the line of Rachel McMinn with Cowen & Company.
Rachel McMinn – Cowen & Company
Thanks very much, and thanks, Ron, for talking about the disappointing news first. I think you're probably the first guy I've talked to this year to do that. Can you talk about, a little bit more about the specific doses that were used in the Japanese study, and if you think that – if you do think that there could be any implications here, or there's just not enough experience? I guess I don't understand why pain in Japan would be a problem.
Ron Barrett
Yes. Astellas has not disclosed the doses that they used in this study other than to say they had three dose levels. I think the – we've only had this data a little bit of time and have had limited amount of opportunity to really dig into it. But I would remind people that, as I said in the prepared remarks, that there's no history of conducting these types of pain studies in this population in Japan. So there are a number of factors that could come into play. Because there are no approved treatments in Japan for painful diabetic neuropathy, we don't know what type of patient may enter into a clinical trial and whether that differs from the types of patients that enter into trials in US trials, for instance.
So it's things like disease severity. In painful diabetic neuropathy, that's a very important parameter because, as you know, as these patients, if they don't have good glucose control, their peripheral neuropathy gets worse and their ability to either report pain or report improvement in pain may be diminished. And so these are the types of factors that we're looking at. It's possible there also could be cultural issues with regard to how patients report pain on this 11-point pain scale. So these are things that we and Astellas are looking at. We'll be talking with experts and deciding what to do next.
Rachel McMinn – Cowen & Company
And so is it fair to assume, then, that there's been no gabapentin studies at all in Japan? Or are there any other similar indications where you can look and, I guess, try to understand, as you mentioned earlier, the potential placebo response and whether or not it's perhaps more magnified in this population than what you would see in other, US-based studies?
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