(a) What were the original eligibility criteria for participants in recruited into this study as described in the 2012 methods paper?

(b) On page e34 (3) of the 2018 paper, the authors provide information on 425 additional participants. Why was it important to note this additional recruitment information?

2012 methods paper:

https://academic.oup.com/ije/article/41/2/377/690923

2018 paper:

https://www.nejm.org/doi/10.1056/NEJMoa1800389?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov