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The present invention further provides accordingly, D 90 particle size of the unformulated amorphous varenicline or its L-tartrate salt obtained by the process of present invention is used as starting material in preparing a pharmaceutical composition generally is less than 400 microns preferably less than about 200 microns, more preferably less than 150 microns, still more preferably less than about 50 microns and still more preferably less than about 15 microns.

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Continuous abstinence during weeks 9 to 12 was approximately 44% for varenicline compared with approximately 30% for bupropion SR and 18% for placebo.

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Two separate case reports also showed no development of psychiatric AEs with varenicline in a patient with schizophrenia 37 and a patient with bipolar disorder.

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Although findings suggested a benefit, there were too few studies and the studies were too heterogeneous to draw definitive conclusions.

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In 12 trials losses to follow-up were higher in the varenicline group than the placebo group, whereas in 17 trials losses to follow-up were higher in the placebo group than the varenicline group.

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These adverse effects were not noted in any of the clinical trials with varenicline and will require additional study to determine if they are causally related to the use of varenicline.

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