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seeing the HbA1c change they took, and I hope I am right about this, the value right

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before they had to go on the rescue medication. So that’s just for the purposes of

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determining how much of an HbA1c change there was.

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analyses stop when you need to be rescued then you only count the value that

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occurred right before rescue’. My first reaction to that was, Oh, that’s kind of icky

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because those are not randomized sub groups. on the other hand, it’s consistent with

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what we do in blood pressure trials, which is, if you are trying to look at the change in

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blood pressure someone who hits a level that where they need to be treated with

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something else we do take the last, I mean we have in the past taken the last, observation

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right before they went on that additional medication. So it’s consistent with what we

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have done when I was at NHLBI in those blood pressure trials. So I think it makes sense.

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I am concerned about lumping them all together partially because it’s such small

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numbers. You would think that the people who go on to the rescue probably are at an

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increased risk of events. So on the one hand I was little bit curious about did the events

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all occur in the people who went on to rescue or was it evenly split between the people

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who stayed in their study and didn’t need rescue.

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be wrong on this but, what you were just saying is implying that if someone in the short-

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term trial if they needed glycemic rescue they weren’t included in the long-term trial.

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DR. BURMAN: Point of clarification is that correct?

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DR. WOLF: Yes.

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DR. BURMAN: Thank you. Are there any other comments?

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DR. WYNE: I just had a brief comment about these events. I don’t think

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DR. BURMAN: If I may, for a point of clarification and I definitely could

DR. PROSCHAN: No, no, no. What I am saying is, for the purpose of

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