It remains unclear how the larger statistical and funding communities will respond.
In Germany and most European countries, the approval procedure for AR includes applications (>6,000 words) covering all analysed readouts: anaesthesia, pain control, euthanasia methods, termination criteria, statistical planning, funding, discussion of reduction, refinement and replacement, and a systematic review.
SR provided independent statistical services, funded by Janssen Pharmaceutica.
The authors would also like to thank Susan Cheer and Richard Barry (Quintiles Medical Communications), who provided medical writing support, and Maria Efstathiou (Quintiles Biostatistics), who provided statistical support, funded by Medtronic.
Information collected included study design, objectives, patients, outcome measures, results, statistical methods and funding sources.
T.A.G.: study concept and design, critical revision of manuscript for important intellectual content, statistical analysis, obtained funding, and study supervision.
YWK: acquisition of data; analysis and interpretation of data; drafting of the manuscript; statistical analysis; obtained funding; study supervision.
MS: conception of study and study design; supervision and on site implementation of study; data acquisition; data analysis; statistical analysis; obtained funding; critical review of the manuscript.
JW contributed to the study conception and design, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, obtaining funding.
JLP and JOM conceived and designed the research, acquired the data, analyzed and interpreted the data, performed the statistical analyses, handled funding and supervision, drafted the manuscript and critically revised the manuscript for important intellectual content.
