A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

Table 5 Follow-up visits: estimated visit dates and corresponding window limits

Time point	Estimated visit date, calculated from date of birth	Window limits of estimated visit date
Time point	Estimated visit date, calculated from date of birth	Earliest	Latest
12 months	52 weeks¹	6 months arm: − 4 weeks	+ 48 weeks (equivalent to 23 months of age)²
12 months	52 weeks¹	12 months arm: − 2 weeks	+ 48 weeks (equivalent to 23 months of age)²
3 years	156 weeks	− 4 weeks	+ 48 weeks (equivalent to 3 years 11 months of age)
5 years	260 weeks	− 4 weeks	+ 48 weeks (equivalent to 5 years 11 months of age)

¹Corrected for gestational age. Full term is defined as day 1 of the 40th week of pregnancy
²Speech assessments vary in their latest acceptable date:
• Six months surgery patients should have their speech assessed by + 26 weeks (equivalent to 18 months of age)
• Twelve months surgery should have their speech assessed before surgery

ISSN: 1745-6215