Received: 11 August 2021
Accepted: 23 March 2022
First Online: 10 April 2022
: The methods performed in this study were in accordance with the relevant guidelines and regulations of the Declaration of Helsinki. This study was approved by the relevant ethics committees at the institutions conducting the study at each site prior to the initiation of study activities. The study was also approved by the ethics committees at the partner U.S.-based institutions (University of North Carolina at Chapel Hill, Columbia University, University of Alabama at Birmingham and Indiana University) and by RTI International, the data coordinating center. All women provided informed consent prior to their participation in the sub-study. The ASPIRIN trial was registered in clinicaltrials.gov (NCT02409680).
: Not applicable.
: The authors declare that they have no competing interests.