"The real issue is the Hologic then changed the study, which the original submission described how the 2-3 month post procedure bleeding scores were known at the time of enrollment, by removing this information and then stating that "No subject's post-procedure bleeding status was reviewed, queried, nor known at enrollment, in either study arm." They realized no one would publish it the previous way, and lied, misled, what ever you want to call it, in order to get their headlines.
They did not anticipate the original study submission to be in the hands of people who have the balls to stand up and call them out finally on their bullshit."
Now here's where you're fucked: the study, and the cohort, never changed. Their first report (go ahead and put it online so you have another lawsuit) contains the exact same enrollment criteria, primary efficacy outcome (amenorrhea at or beyond,not before, minimum of 3M follow-up), and no women's results were ever omitted in the paper's evolution. Jackass. This was basically a patient-reported satisfaction report, but early drafts contained limited physician-charted "bleeding status" data--because only 2/3 or women returned for follow-up at a median of <30 days post-procedure, and less than half of them had any bleeding status recorded (this was a "hey, how're you feeling" visit), the data was of limited utility or meaningfulness. The authors appreciated that valid reviewer comment, so those incomplete data were omitted and this was patient-only. The EXACT same cohort, without a single omission, but it's a survey so it had a 100% response (not participation) rate.
Asswipe Clapper's trying to distort reality saying that the cohort changed after (less than half) of women's "2-3 month" bleeding status was used to select subjects. That is a joke. And that is precisely why Dove Press/Taylor Francis parent company--both of their legal teams--are laughing at your pathetic efforts to denigrate a solid study. Limitations? Yes, of course, like any study (e.g., using heme alkaline assay to confirm amenorrhea--doesn't work; not anymore). But the facts are the facts, whether you like them or not.
Otherwise your frantic efforts would have resulted in that paper being retracted instead of simply delayed by your nonsense.
Now we will argue in Letters-to-the-editor, which I'm drooling waiting for because I'm going to tear you a new asshole.
You are a lying, deceitful man who tried to denigrate completely the reputations of 4 excellent surgeons, and good men (collateral damage to you, asswipe), and it's didn't work.
Your ruse was exposed and you are pathetic.
You don't matter anymore.
