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Ethics approval and consent to participate This study was conducted according to the principles of the Declaration of Helsinki [59]. Ethical approval for the study protocol was given by the Freie Universität Berlin Ethical Review Board (161/2017) for the trial in Germany and by the Swedish Ethical Review Authority (2020 − 00261) for the trial in Sweden. Both studies were also reviewed and approved by the WHO Research Ethics Review Committee (ERC.0003321).
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