Table 2.
Author | Random allocation | Allocation concealment | Blinding | Any loss to follow-up | Analysis |
Heinrich et al, 2014[8] | PY | NR | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Pillai et al, 2016[9] | DY | PY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Mir et al, 2017[10] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Rajan et al, 2018[11] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Lodenius et al, 2018[12] | PY | CN | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 98.8% of randomized patients |
Ng et al, 2018[13] | DY | DY | Patients: CN; caregivers: CN; data collectors: CN; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 96.0% of randomized patients |
Hanouz et al, 2019[14] | PY | PY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Vourc’h et al, 2019[15] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Wong et al, 2019[16] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 100% of randomized patients |
Tremey et al, 2020[17] | DY | PY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: DY for efficacy outcomes Data for primary efficacy assessment available for 98.4% of randomized patients |
Hua et al, 2020[18] | DY | PY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 98.3% of randomized patients |
Sjöblom et al, 2021[19] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 99.7% of randomized patients |
Osman et al, 2021[20] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 94.3% of randomized patients |
Lyons et al, 2021[21] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 91.1% of randomized patients |
Rosén et al, 2021[22] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 90.0% of randomized patients |
Zhou et al, 2021[23] | DY | DY | Patients: CN; caregivers: CN; data collectors: NR; adjudicators: NR; data analysis: NR. | CN | ITT: PN for efficacy outcomes Data for primary efficacy assessment available for 85.0% of randomized patients |
CN = certainly no, DY = definitely yes, ITT = intention to treat, NR = not reported, PN = probably no, PY = probably yes.