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Sample size calculations We expect that as many as 15% of the enrolled women will be lost to follow-up because of abortions, stillbirths and migration (see table 1)

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Up to 55% of patients developed anti-drug antibodies [65], which were associated with systemic allergic reactions in approximately 5% of cases and injection-site hypersensitivity, including anaphylaxis, which necessitated early trial termination [66, 67]