Two separate randomization lists were generated using an in-house computerized randomization schedule - Strata one for baseline Hb>70 g/L and strata two for baseline Hb≤70 g/L.
Preclinical data indicated that more frequent vaccinations enhance the generation of the antigen specific immune responses which supports the use of the more intensive schedule in this stratum [CureVac, data on file].
To balance population representatives in both treatment groups, four strata are constructed with separate randomisation schedules: (1) age 70 to 80 years, planned surgery on admission; (2) age 70 to 80 years, no planned surgery on admission; (3) age 80 years or over, planned surgery on admission; (4) age 80 years or over, no planned surgery on admission.
As the PFS for patients with squamous histology is expected to be lower than for patients with non-squamous histology, individuals recruited to strata 2 will receive a more intense vaccination schedule with six vaccinations until Day 57.
Allergan Biostatistics prepared the randomisation schedule and each investigator was assigned blocks for each IOP stratum.
We used a systematic block randomization schedule to make mode assignments within each of the six marital status/partner gender strata to control for the long recruitment period and non-probability based sampling methods.
An independent statistician prepared the computer generated randomisation schedule using a block size of two to maintain balance between treatment arms within each stratum.
The allocation sequences within each strata will be pre-generated by the unblinded trial manager and documented in the randomisation schedule prior to trial commencement.
Analysis of individual strata with large sample sizes, such as screening hemoglobin <or ≥10 g/dL for each dosing schedule (QW, Q2W, or Q3W), showed a similar lack of differences between treatment groups.
32 We calculated the proportion of schedule II opioid prescriptions dispensed to doctor shoppers per total opioid prescriptions for each community-year stratum.
We then extrapolated the pooled efficacy for a 2- or 3-dose schedule obtained from Malawi (49.5%) [ 10] to GAVI-eligible countries that belong to the "high" child mortality stratum and the corresponding data from South Africa (76.9%) [ 10] to the countries that fall on "intermediate" strata.
