At 12months , the annualised rate of death ( rhEPO 0.11 , 95 % CI 0.06 to 0.20 ; placebo : 0.08 , CI 0.04 to 0.17 ) , tracheotomy or > 23h NIV ( rhEPO 0.16 , CI 0.10 to 0.27 ; placebo 0.18 , CI 0.11 to 0.30 ) did not differ between groups , also after stratification by onset and ALSFRS-R at baseline .