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Additional inclusion criteria were as follows: age between 18 and 65 years (inclusive), a body mass index (BMI) between 18 and 30 kg/m 2 (inclusive) and the ability to read and understand the written consent form, complete study-related procedures and communicate with the study staff

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While the FDA's decision has no bearing on access in other countries, it does build momentum for other regulatory authorities to approve the drug, says Carmen Pérez Casas , senior strategy lead at Unitaid, a United Nations agency that helps reduce the cost of treatments for HIV/AIDS, TB and malaria