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concern about, maybe I am missing something but I don’t have too much concern about

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combining the long-term and short-term in this case. You know, from what I understand

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randomization was retained, blinding was retained, and it was a mixture between patients

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who simply continued the short-term and those who had glycemic rescue. I am not

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seeing a major problem with combining these populations. I don’t know what others

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think.

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by saying I think the fact that they were rescued means that they didn’t respond very well

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to the first therapy. So it does potentially alter the long-term therapy and I think we heard

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some statistical analyses that try to take those into account. The trials are imperfect but

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nonetheless in the real world seem reasonable. So does anybody have any further

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discussion on, important discussion on the long-term assessments and how they were

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done?

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issue that Michael brought up of, what are the cardiovascular effects of the other

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medications? So it is kind of beginning to mix apples and oranges a little bit but some

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people are going through one treatment and some people are really not on the treatment

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they were originally randomized, so they have added another treatment that may also

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affect their cardiovascular risk. So I think it just muddies the waters a little bit.

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This question is open for a discussion. Well, I can start the discussion

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DR. KONSTAM: Well, you know, I guess I just don’t have too much

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DR. BURMAN: Dr. Flegal?

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DR. FLEGAL: Well, I also, I don’t see a major problem but there is the

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DR. BURMAN: Mike.

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DR. PROSCHAN: Yeah, I think from the standpoint of the HbA1c and

the short-term trial, when I first looked in the booklet and I saw that it said, ‘all the

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