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The study was sponsored by Novartis Pharma, was created by the sponsor in collaboration with an academic executive committee, and was monitored by an independent data and protection monitoring committee .11 Data were collected, managed, and analyzed by the sponsor, with oversight by the executive committee, and analyses were replicated by an unbiased academic statistician from the London School of Hygiene and Tropical Medication. The manuscript was prepared by the composing group , whose users had unrestricted usage of the data, and was revised by all the authors subsequently.


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