1 Both on-treatment and intention-to-treat
analyses were done.
2 Analyses were done according to an intention-to-treat princip
3 icosteroids, or end-study 25(OH)D levels; post-hoc subgroup
analyses were done according to sex and study duration.
4 All effectiveness
analyses were done according to the intention-to-treat princi
5 Analyses were done according to the randomised FREEDOM treatm
6 Safety
analyses were done according to treatment received.
7 Matched and unmatched (controlling for age) bivariate
analyses were done and risk factors for illness were expresse
8 All
analyses were done at individual country level and grouped by
9 Efficacy
analyses were done based on the full analysis set.
10 All safety
analyses were done based on the safety set, which included al
11 itive-deterioration-free survival and overall survival, and
analyses were done by intention to treat.
12 Additional sensitivity
analyses were done,
excluding patients who stopped treatment
13 Cutoff
analyses were done for clinical applicability: individuals ar
14 Data
analyses were done from March to September 2016.
15 The
analyses were done in accordance with the intention-to-treat
16 assessed according to the Lugano classification, and safety
analyses were done in all participants.
17 Safety
analyses were done in all patients for whom data was availabl
18 Safety
analyses were done in all patients who received any amount of
19 ll patients who were randomly assigned to treatment; safety
analyses were done in all patients who received at least one
20 Safety
analyses were done in all patients who received at least one
21 Analyses were done in all patients who were randomly assigned
22 Analyses were done in intent-to-treat and evaluable populatio
23 Analyses were done in men and women.
24 Analyses were done in the intention-to-treat and per-protocol
25 Analyses were done in the intention-to-treat population, and
26 Primary and safety
analyses were done in the intention-to-treat population.
27 Efficacy
analyses were done in the intention-to-treat population.
28 utcome measure was overall survival, and primary and safety
analyses were done in the intention-to-treat population.
29 Analyses were done in the modified intention-to-treat populat
30 were done in the intention-to-treat population, and safety
analyses were done in the per-protocol population.
31 Safety
analyses were done in the safety population, consisting of al
32 reat population (all randomly assigned patients) and safety
analyses were done in the treated population (all randomly as
33 Analyses were done on a modified intention-to-treat basis.
34 The safety and efficacy
analyses were done on all patients who received at least one
35 ions in both studies were not masked and primary and safety
analyses were done on an intention-to-treat basis.
36 Analyses were done on an intention-to-treat basis.
37 Ontology and pathway
analyses were done on lists of genes putatively disrupted by
38 Analyses were done on the full analysis set, consisting of al
39 All immunogenicity and safety
analyses were done on the full analysis set, including partic
40 Efficacy
analyses were done on the intention-to-treat population, wher
41 The efficacy
analyses were done on the intention-to-treat population; safe
42 Analyses were done per protocol for all patients who commence
43 Efficacy and safety
analyses were done per protocol.
44 Subgroup
analyses were done to determine whether effects of vitamin D
45 Characteristics of patients were compared and survival
analyses were done to evaluate the effect of infection status
46 Random-effects meta-
analyses were done to investigate between-study heterogeneity
47 Additional spectroscopic and structural
analyses were done to track the dependencies between the proc
48 Analyses were done using a treated-as-randomised approach.
49 All
analyses were done using the modified intention-to-treat popu
50 All
analyses were done with the modified intention-to-treat popul