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Primary Outcome Measures: 1. Any occurrence of an unforeseen safety pattern up to 1 year follow-up Other Pre-specified Outcome Measures: Overall mortality and survival rates up to 1 year follow-up 6. Outcome of pregnancies: rates of miscarriage, stillbirths, APGAR score looking for fun over escodt birth, congenital malformations up to 1 year follow-up 4.
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