Study design
Details of the SALTO trial were published previously [This observational long-term follow-up study was approved by the ethical research committee (METC) of the Máxima Medical Centre (file number METC W17.015, CCMO NL60618.015.17) and by the board of directors of each of the participating hospitals, separately from the original SALTO trial. This trial was registered in the Dutch Trial Register (NTR6330). The study was developed and described in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [