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All 148 glorious pages are available at www.FDARestasisdata.org. I would not recommend those with DES trying to read this.
The goal of Allergan was to reach Schirmer testing of >10mm. Several attempts were made and rejected. Then Restasis with punctal plugs was included in the study. At last the goal was achieved. Also the ITT (Intend to Treat) group was reduced to 43% of the original number by using only post menapausal women and those with Sjogrens. The study time was also increased from two months to six months.
The goal of Allergan was to reach Schirmer testing of >10mm. Several attempts were made and rejected. Then Restasis with punctal plugs was included in the study. At last the goal was achieved. Also the ITT (Intend to Treat) group was reduced to 43% of the original number by using only post menapausal women and those with Sjogrens. The study time was also increased from two months to six months.
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