Question-and-Answer Session
Operator
Thank you. (Operator Instructions). Our first question comes from Brian Abrahams with Oppenheimer & Company.
Brian Abrahams - Oppenheimer & Company
All right, thanks very much for taking my question and congratulations on getting the Daisy Petal study started so quickly. I have couple of questions regarding some of the modifications, the amendments that you have made to that study I guess. Can you give us a sense of what your initial target was for the mean base line score with this modified pain scale?
Chris O'Brien
In the clinical trial, you have certain assumptions that go into any kind of simplified estimate in power calculation. And we know that for these 0 to 3 scale there are 4 point scales that the FDA has been in favor of and we know that a moderate to severe is a score of 2 or greater for things like dysmenorrhea which is the most disabling and intense symptom of endometriosis. We typically see scores in the 2, 2.5, 2.6 range and that’s indeed what we are seeing here.
As you know in the Lilac Petal Study with that version of the scale, about 40% of the daily values during the placebo lead-in period were zero and 40% of the values were one. And the base line value on the non-menstrual days was kind of 0.83 or if you look at all days rolled up it was 0.9. That value just doesn’t give you any room to improve. So what we have done with this population in 901 is make sure that the scale is appropriate that has a wide dynamic range and that women enrolling in the trial are women who have moderate to severe endometriosis with moderate to severe and non-menstrual pain and moderate to severe dysmenorrheal. And such I would expect the main scores to be somewhere in the 1.5 to 2 range considering that most women with moderate to severe endometriosis only have about 8 to 10 days per months of non-menstrual symptoms.
Brian Abrahams - Oppenheimer & Company
It seems like you are in a better place than you were with the prior scale but I am just wondering if you think the modifications were as successful as you had hoped where you hoped. I do hope to fall into the closer to the two to three range for the value to detect a greater difference.
Chris O'Brien
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